Clinical Pharmacology in Drug Development最新文献

{"title":"Pharmacokinetics, Pharmacodynamics, and Safety of Single-Dose Luseogliflozin (TS-071) in Japanese Children and Adolescents With Type 2 Diabetes: A Multicenter, Open-Label, Parallel-Group Phase 1 Study.","authors":"Toru Kikuchi, Hidefumi Nakamura, Hideo Umeuchi, Iwao Kitajima, Tatsuhiko Urakami","doi":"10.1002/cpdd.70065","DOIUrl":"https://doi.org/10.1002/cpdd.70065","url":null,"abstract":"<p><p>This study aimed to evaluate the pharmacokinetics, pharmacodynamics, and safety of a single dose of luseogliflozin (TS-071), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, in Japanese children and adolescents with type 2 diabetes, with the goal of informing dose selection for future research. In this multicenter, open-label, parallel-group Phase 1 trial, patients aged 9-17 years received a single oral dose of luseogliflozin at 1.25, 2.5, or 5 mg. Pharmacokinetic and pharmacodynamic parameters were assessed and compared with existing adult data. In total, 19 patients completed the study. The mean age was 14.3 ± 1.9 years, and the mean body weight was 77.28 ± 25.32 kg. Plasma luseogliflozin concentrations increased in a dose-dependent manner. The maximum plasma concentration and the area under the curve were comparable to those observed in adults. Administration of luseogliflozin at all dose levels resulted in a substantial increase in urinary glucose excretion. No safety concerns emerged from the single-dose administration. Luseogliflozin demonstrated favorable pharmacokinetic, pharmacodynamic, and safety profiles in pediatric patients, consistent with adult findings. These results support the selection of 2.5- and 5-mg doses for a future Phase 3 pediatric study.</p>","PeriodicalId":10495,"journal":{"name":"Clinical Pharmacology in Drug Development","volume":"15 4","pages":"e70065"},"PeriodicalIF":1.8,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13108376/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147764825","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Single-Dose Bioequivalence Study of Elagolix Tablets 200 mg (Test Product) and Elagolix Tablets 200 mg (Reference Product) in Healthy Non-Pregnant, Non-Lactating Premenopausal Female Subjects Under Fasting Conditions","authors":"Sudershan Kumar,&nbsp;Arshad Khuroo,&nbsp;Reshma Quadros,&nbsp;Shruti Dharmadhikari,&nbsp;Chintan Khandhedia,&nbsp;Gaurav Puppalwar,&nbsp;Amey Mane","doi":"10.1002/cpdd.70053","DOIUrl":"10.1002/cpdd.70053","url":null,"abstract":"<p>Elagolix is a short-acting oral gonadotropin-releasing hormone antagonist utilized for treating endometriosis-associated pain by rapidly suppressing gonadotropins and estradiol. Although well characterized in Western populations, clinical data regarding its use in Indian women remain limited. This study evaluated the pharmacokinetics, safety, and bioequivalence of a test 200 mg Elagolix tablet against a reference formulation under fasting conditions. The randomized, open-label, four-period crossover trial involved 60 healthy women aged 18-40 years who received single oral doses of either formulation. Plasma concentrations were monitored via validated UHPLC-MS/MS for 24 h post-dose. Fifty-nine participants completed the study, with results indicating rapid absorption (median T_max 1.25-1.50 h) and a mean half-life of approximately 2.1-2.2 h. Bioequivalence was established as the 90% confidence intervals for key pharmacokinetic parameters—C_max, AUC_0-t, and AUC_0-∞—fell within the regulatory 80%-125% acceptance limits. Specifically, the median AUC_0-t was 3341.23 ng h/mL for the test product compared to 3365.30 ng h/mL for the reference. Both formulations exhibited comparable safety profiles, with only five mild, resolvable adverse events reported. These findings confirm that the test formulation is bioequivalent to the reference standard, supporting its viability as a safe and effective therapeutic alternative.</p>","PeriodicalId":10495,"journal":{"name":"Clinical Pharmacology in Drug Development","volume":"15 4","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13038420/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147590368","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacokinetics and Bioequivalence of 2 Deutetrabenazine Tablets in Healthy Chinese Volunteers Under Fasting and Fed Conditions","authors":"Dayong Xu,&nbsp;Pengkai Wang,&nbsp;Yuan Li,&nbsp;Ping Zhang,&nbsp;Liying Wei,&nbsp;Xiaolian Xiong,&nbsp;Xin Li","doi":"10.1002/cpdd.70054","DOIUrl":"10.1002/cpdd.70054","url":null,"abstract":"<p>Deutetrabenazine, a deuterated vesicular monoamine transporter 2 (VMAT2) inhibitor, is approved for the treatment of Huntington's disease (HD)-related chorea and tardive dyskinesia (TD). However, pharmacokinetics (PK) and bioequivalence (BE) evidence in the Chinese population has been lacking. This single-center, randomized, open-label, single-dose, two-formulation, four-period, fully replicated crossover study evaluated the PK, BE, and safety of test and reference deutetrabenazine 12 mg tablets under fasting and fed conditions in healthy Chinese volunteers. A total of 90 subjects were enrolled (40 fasting; 50 fed), and 88 completed the study. Plasma concentrations of deutetrabenazine and its active metabolites d6-α-dihydrotetrabenazine (d6-α-HTBZ) and d6-β-dihydrotetrabenazine (d6-β-HTBZ) were quantified using a validated liquid chromatography-tandem mass spectrometry method. BE was assessed using average bioequivalence (ABE) or reference-scaled average bioequivalence (RSABE) according to within-subject variability. Under fasting conditions, RSABE was applied for maximum plasma concentration (C_max) and met equivalence criteria (point estimate within 80%–125%, upper confidence interval bound ≤ 0); under fed conditions, as well as for all remaining PK parameters, ABE criteria were met with the 90% confidence interval within the 80%–125% range. Both formulations were well tolerated, with only mild and transient adverse events and no serious safety findings. These results demonstrate that the test and reference deutetrabenazine tablets are bioequivalent in healthy Chinese adults under both nutritional states.</p>","PeriodicalId":10495,"journal":{"name":"Clinical Pharmacology in Drug Development","volume":"15 3","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147497529","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of High-Fat Diet on Pharmacokinetics and Incidence of Adverse Reactions of Tacrolimus in Healthy Chinese Participants","authors":"Xiufang Zhu,&nbsp;Lingxue Shi,&nbsp;Lan Yang,&nbsp;Nana Zhang,&nbsp;Yujie Wu,&nbsp;Peihua Yin,&nbsp;Jianxin Wang,&nbsp;Chunhua Zhou","doi":"10.1002/cpdd.70049","DOIUrl":"10.1002/cpdd.70049","url":null,"abstract":"<p>The effects of food on the pharmacokinetics (PKs) and safety of 1 mg Tacrolimus sustained-release Tacrolimus capsules in healthy Chinese subjects were investigated from one bioequivalence trial. The bioequivalence trial was designed as single-center, openlabel, randomized, single-dose, two-sequence, four-period crossover under both fasted and fed conditions. A total of 80 healthy subjects were enrolled. These subjects received a single oral 1 mg dose of Tacrolimus with a 14-day washout between four periods. Serial PK samples were collected and blood concentrations were analyzed using validated high-performance liquid chromatography–mass spectrometry. Pharmacokinetic parameters were calculated by noncompartmental methods. The BE module of WinNonLin was used for statistical analysis of the maximum concentration (C_max), the area under the concentration–time curve from zero to the final measurable concentration (AUC_0–t), and the area under the concentration–time curve from time zero to infinity (AUC_0–∞) of Tacrolimus in blood.</p><p>The mean values of all pharmacokinetic parameters were similar for the T and R formulations under fasting and fed conditions, and the 90% confidence intervals were inside the 80.00%–125.00% range. For both the T and R formulations, the AUC_0–t and AUC_0–∞ values were higher in the fed test than in the fasting one. The incidence of adverse events (AEs) was similar between the fasted and fed states, and no serious AEs were observed. Fasting significantly increased the exposure of Chinese subjects to 1 mg Tacrolimus.</p>","PeriodicalId":10495,"journal":{"name":"Clinical Pharmacology in Drug Development","volume":"15 3","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13006711/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147497549","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Thorough QT Study on the Effect of Therapeutic and Supratherapeutic Dosing of Givinostat in Healthy Volunteers","authors":"Eugenio Mercuri,&nbsp;Barry Byrne,&nbsp;Tracey Willis,&nbsp;John Bourke,&nbsp;Paolo Bettica,&nbsp;Sara Cazzaniga,&nbsp;Hongqi Xue,&nbsp;Borje Darpo","doi":"10.1002/cpdd.70047","DOIUrl":"10.1002/cpdd.70047","url":null,"abstract":"<p>Givinostat is a class I/II histone deacetylase inhibitor indicated for Duchenne muscular dystrophy (DMD). The study evaluated the effect of therapeutic and supratherapeutic givinostat doses on the QT/QTc interval. Healthy volunteers received each treatment—givinostat hydrochloride monohydrate oral suspension as a therapeutic (100 mg) or supratherapeutic (300 mg) dose, placebo oral suspension, or moxifloxacin oral tablet (positive control, 400 mg)—according to a block randomization scheme. Cardiodynamic assessments were paired with pharmacokinetic samples. A small, clinically non-relevant effect on mean placebo-corrected, change-from-baseline QTcF (∆∆QTcF) of 5.5 ms was seen after givinostat 100-mg dose. Clinically relevant QTc prolongation was observed with the supratherapeutic dose, with a mild ∆∆QTcF increase of 13.6 ms. A delay of ≈3 h between T_max and the largest effect on the QTc interval was seen for both doses. In the concentration-QTc analysis, an E_max model captured the data better than the prespecified linear model and showed that an effect on ∆∆QTcF exceeding 10 ms could be excluded within the full range of observed givinostat concentrations in this study and up to ≈745 ng/mL. Givinostat at the maximum labeled dose (up to 53.2 mg twice daily for DMD) is not expected to pose a QT prolongation risk.</p>","PeriodicalId":10495,"journal":{"name":"Clinical Pharmacology in Drug Development","volume":"15 3","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13006724/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147497463","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacokinetic Evaluation of a Fixed-Dose Combination of Pelubiprofen and Tramadol: A Randomized Crossover Relative Bioavailability Trial and a Fixed-Sequence Food-Effect Study in Healthy Volunteers","authors":"Bui Thi Tham,&nbsp;Tran Thi Ngan,&nbsp;Tran Van Anh,&nbsp;Kim Dong Chool,&nbsp;Lee Ah Ram,&nbsp;Park Sang Wook,&nbsp;Lee Soo Bok,&nbsp;Oh Dong Ho,&nbsp;Nguyen Van Khai,&nbsp;Nguyen Thi Thu Phuong","doi":"10.1002/cpdd.70050","DOIUrl":"10.1002/cpdd.70050","url":null,"abstract":"<p>DW-1021 is a novel fixed-dose combination salt formulation containing pelubiprofen 45 mg and tramadol hydrochloride 45.9 mg (equivalent to 40.3 mg tramadol free base). Two open-label, phase I clinical studies were conducted in healthy Vietnamese male volunteers to characterize the pharmacokinetics of DW-1021. The relative bioavailability study employed a randomized, single-dose, two-period, two-sequence crossover design (n = 14) comparing DW-1021 with co-administration of Pelubi CR (pelubiprofen 45 mg) and Zytram CR (tramadol hydrochloride 75 mg, equivalent to 65.9 mg tramadol base) under fasting conditions. The food effect study used a fixed-sequence, two-period design (n = 14) to evaluate DW-1021 under fasting and fed (high-fat, high-calorie) conditions. In the relative bioavailability study, DW-1021 resulted in lower exposure to pelubiprofen (AUC_0-t GMR: 86.68%) and generally comparable exposure to trans-OH-pelubiprofen (AUC_0-t GMR: 108.74%) compared with the reference treatment. For tramadol, unadjusted comparisons showed a higher peak concentration (C_max GMR: 192.17%) but lower overall exposure (AUC_0-t GMR: 79.30%). After dose normalization, tramadol exposure per unit dose was higher (AUC_0-t/Dose GMR: 129.58%). In the food effect study, fasting conditions were associated with higher C_max and AUC_0-t of pelubiprofen (GMRs: 109.92% and 140.48%, respectively). Food increased tramadol C_max, while AUC_0-t remained largely comparable between conditions. All adverse events were mild to moderate, and no serious adverse events were reported. In conclusion, DW-1021 exhibited analyte-dependent pharmacokinetic differences relative to the reference treatment. Food intake primarily reduced pelubiprofen exposure, while tramadol AUC_0-t was minimally affected, with a modest increase in C_max under fed conditions.</p>","PeriodicalId":10495,"journal":{"name":"Clinical Pharmacology in Drug Development","volume":"15 3","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147442837","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A pharmacokinetics study to evaluate drug–drug interactions between fipaxalparant and concomitant medications in healthy participants","authors":"Yang Song,&nbsp;Krischan Hudson,&nbsp;Zhan Ye,&nbsp;Lisa Hawley,&nbsp;Brajesh Pandey,&nbsp;Jennifer Zarzoso,&nbsp;John Rogowski,&nbsp;Yajing Sun,&nbsp;William A. Rees,&nbsp;Yan Xin","doi":"10.1002/cpdd.1621","DOIUrl":"10.1002/cpdd.1621","url":null,"abstract":"<p>Fipaxalparant, a small molecule and negative allosteric modulator of lysophosphatidic acid receptor 1, is being evaluated in phase 2 clinical trials of idiopathic pulmonary fibrosis (IPF) and diffuse cutaneous systemic sclerosis. This phase 1, open-label, crossover, 3-cohort study in healthy adults evaluated mutual drug–drug interactions (DDIs) between fipaxalparant and the IPF medications pirfenidone and nintedanib, as well as the effects of itraconazole (P-glycoprotein inhibitor) and rifampin (potent organic anion transporting polypeptide [OATP] inhibitor) on fipaxalparant. Participants received a single oral dose of fipaxalparant 300 mg. Overall, 16, 20, and 15 participants completed the study in cohorts 1, 2, and 3, respectively. The study demonstrated no relevant mutual DDIs between fipaxalparant and pirfenidone/nintedanib at clinical doses. There was no effect of itraconazole 400 mg on fipaxalparant exposure. A single rifampin 600 mg dose caused 1.48-fold and 1.86-fold increases in fipaxalparant <i>C</i>_max and AUC_0–∞, respectively. Treatment-emergent adverse events were mild/moderate with fipaxalparant alone or with the other study drugs. Overall, fipaxalparant absorption in vivo occurs independently of the P-glycoprotein–mediated gut efflux pathway, and fipaxalparant is a clinically relevant OATP substrate. Results of this DDI study will inform the management of concomitant medications of ongoing/future trials of fipaxalparant.</p>","PeriodicalId":10495,"journal":{"name":"Clinical Pharmacology in Drug Development","volume":"15 3","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145548571","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacokinetics and Bioequivalence of Ilaprazole Enteric-Coated Tablets in Healthy Chinese Volunteers: A Two-Sequence, Four-Period, Fully Replicated Crossover Study","authors":"Lijie Du,&nbsp;Yi Zhang,&nbsp;Fangliang Gan,&nbsp;Jiamin Yang,&nbsp;Li Li","doi":"10.1002/cpdd.1628","DOIUrl":"10.1002/cpdd.1628","url":null,"abstract":"<p>Ilaprazole enteric-coated tablets are a novel proton pump inhibitor primarily used for the treatment of gastroesophageal reflux disease, with metabolism not affected by CYP2C19 genetic polymorphism. This study evaluated the pharmacokinetics and bioequivalence of two formulations of ilaprazole enteric-coated tablets in Chinese healthy volunteers under fasting and fed conditions using a single-center, randomized, open-label, single-dose, two-formulation, four-period, two-sequence, fully replicated crossover design. A total of 72 volunteers were enrolled, with 36 in each group. In the fasting group, volunteers received a single dose of 5 mg of the test or reference formulation in each period, while in the fed group, a high-fat meal was consumed 30 min before drug administration. Blood samples were collected within 36 h postdose, and plasma concentrations of ilaprazole were analyzed using ultra-performance liquid chromatography-tandem mass spectrometry. The geometric means and 90% confidence intervals of AUC_0–t, AUC_0–∞, and C_max for both fasting and fed conditions were within the 80%–125% bioequivalence range, and the upper limit of the one-sided 95% confidence interval was ≤0. Both formulations demonstrated bioequivalence under these conditions, with no serious adverse reactions observed.</p>","PeriodicalId":10495,"journal":{"name":"Clinical Pharmacology in Drug Development","volume":"15 3","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145630701","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction to “Preclinical and Phase 1 Assessment of Antisense Oligonucleotide Bepirovirsenin Hepatitis B Virus–Transgenic Mice and Healthy Human Volunteers: Support for Clinical Dose Selection and Evaluation of Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses”","authors":"","doi":"10.1002/cpdd.1620","DOIUrl":"10.1002/cpdd.1620","url":null,"abstract":"<p>Han K, Theodore D, McMullen G, et al. Preclinical and phase 1 assessment of antisense oligonucleotide bepirovirsen in hepatitis B virus–transgenic mice and healthy human volunteers: support for clinical dose selection and evaluation of safety, tolerability, and pharmacokinetics of single and multiple doses. <i>Clin Pharmacol Drug Dev</i>. 2022;11:1191–1202. https://doi.org/10.1002/cpdd.1154</p><p>In the article cited above, the authors have determined that an error was present in the Funding section. The corrected Funding section is shown below.</p><p>Funding</p><p>This phase 1 first-in-human study was, at the time of the trial, fully sponsored and funded by Ionis Pharmaceuticals, Inc. (ISIS 50538-CS1). The study has since been acquired by GSK (Study 213725). The preclinical in vitro and in vivo studies (3470-144) were sponsored and funded by Ionis Pharmaceuticals Inc. and supported by a grant from the National Institutes of Health to Stefan Wieland (AI094409).</p><p>We apologize for this error.</p>","PeriodicalId":10495,"journal":{"name":"Clinical Pharmacology in Drug Development","volume":"15 3","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://accp1.onlinelibrary.wiley.com/doi/epdf/10.1002/cpdd.1620","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145376362","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of Efficacy and Safety Profiles Between Omadacycline and Moxifloxacin in Elderly Patients with Community-Acquired Pneumonia: A Randomized, Controlled Trial","authors":"Muming Yu,&nbsp;Xiaorong Wang,&nbsp;Sitong Wu,&nbsp;Zikang Zhou,&nbsp;Yancun Liu,&nbsp;Yanfen Chai","doi":"10.1002/cpdd.1627","DOIUrl":"10.1002/cpdd.1627","url":null,"abstract":"<p>Omadacycline is a novel aminomethylcycline antibiotic that shows non-inferior efficacy to moxifloxacin in adults with community-acquired pneumonia (CAP), but lacking clinical evidence in elderly patients with CAP. This randomized, controlled study aimed to investigate the efficacy and safety of omadacycline in elderly patients with CAP. Eligible elderly patients with CAP were randomized at a 1:1 ratio to the omadacycline group (n = 48) and moxifloxacin group (n = 49) to receive the corresponding agent. The primary endpoint was clinical response. The most common pathogens in the omadacycline and moxifloxacin groups were <i>viridans streptococci</i> (16.7%, 16.3%), <i>Klebsiella pneumoniae</i> (14.6%, 14.3%), and <i>Neisseria sicca</i> (14.6%, 14.3%). Clinical response rate was greater in the omadacycline group compared to the moxifloxacin group (54.2% vs 26.5%, <i>P</i> = .032). The omadacycline group showed higher significant improvement rate (41.7% vs 16.3%, <i>P</i> = .02), but similar complete recovery (12.5% vs 10.2%, <i>P</i> = .737), effective improvement (37.5% vs 59.2%, <i>P</i> = .125), and ineffectiveness (8.3% vs 14.3%, <i>P</i> = .384) rates compared to the moxifloxacin group. Results of C-reactive protein, procalcitonin, and interleukin-6 at baseline and after treatment, as well as their changes did not vary between the omadacycline and moxifloxacin groups (all <i>P</i> &gt; .05). No difference was observed in liver, kidney, and coagulation function parameters between the two groups (all <i>P</i> &gt; .05). Omadacycline indicates greater treatment efficacy and comparable safety profiles versus moxifloxacin in elderly patients with CAP.</p>","PeriodicalId":10495,"journal":{"name":"Clinical Pharmacology in Drug Development","volume":"15 3","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145562620","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}