Clinical Pharmacology in Drug Development最新文献

{"title":"Ethnic Bridging of Votoplam, a HTT Gene Splicing Modifier, Using Pharmacokinetic Comparison Between Caucasian and Japanese Subjects.","authors":"Lucy Lee, Amy-Lee Richards, Prachi Anand, Brian Beers, Lee Golden, Ronald Kong","doi":"10.1002/cpdd.70062","DOIUrl":"https://doi.org/10.1002/cpdd.70062","url":null,"abstract":"<p><p>Votoplam is a novel, orally bioavailable, small molecule HTT gene splicing modifier that is being developed for the treatment of Huntington's disease. A single-dose, open-label, three-dose level (5, 10, 20 mg), parallel group ethnicity study was conducted to evaluate the pharmacokinetics and safety of votoplam in healthy Caucasian versus Japanese participants. Six participants per ethnic group were enrolled at each dose (12 participants per dose level overall). Thirty-five participants (N = 18 Japanese; N = 17 Caucasian) completed the study. Study results showed slightly higher exposure for Japanese participants at all dose levels. AUC_0-last increased by 1.27-, 1.17-, and 1.29-fold, and C_max increased by 1.58-, 1.19-, and 1.61-fold for 5, 10, and 20 mg, respectively, for Japanese compared with Caucasian participants. Doses proportionality was observed for both ethnicities. Few mild and moderate TEAEs were reported and were comparable between Japanese and Caucasian participants. In summary, votoplam pharmacokinetics and safety profiles are similar between healthy Japanese and Caucasian participants when administered in the single dose range of 5, 10, and 20 mg. Therefore, it is expected that dose adjustments should not be necessary in future clinical studies enrolling Japanese participants.</p>","PeriodicalId":10495,"journal":{"name":"Clinical Pharmacology in Drug Development","volume":"15 5","pages":"e70062"},"PeriodicalIF":1.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147764847","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 Phase 1, Open-Label, Single-Dose Study of the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib, an FGFR Inhibitor.","authors":"Wei Zhu, Peter Hellemans, Anna Mitselos, Marc De Meulder, Juhui James Jiao, Hui Tian","doi":"10.1002/cpdd.70061","DOIUrl":"10.1002/cpdd.70061","url":null,"abstract":"<p><p>Erdafitinib, an oral pan-FGFR inhibitor is extensively metabolized in the liver. This open-label, single-dose, phase 1 study evaluated the pharmacokinetics (PK) of erdafitinib in participants with hepatic impairment versus healthy controls. Overall, 26 participants were enrolled. Following a single 6 mg oral dose, the maximum plasma concentration (C_max) of total erdafitinib was reached at median t_max of 3 h across all groups (participants with mild hepatic impairment, moderate hepatic impairment, and control). The geometric mean ratios for free C_max and free AUC_∞, were 96.07% and 95.22% in participants with mild hepatic impairment compared with controls, respectively. The geometric mean ratios for free C_max and free AUC_∞, were 104.8% and 87.51% in participants with moderate hepatic impairment compared with controls, respectively. Single oral doses of erdafitinib were well tolerated across all cohorts, and no new safety signals were noted. The results demonstrate that dose adjustments are not necessary in participants with mild or moderate hepatic impairment receiving oral erdafitinib.</p>","PeriodicalId":10495,"journal":{"name":"Clinical Pharmacology in Drug Development","volume":"15 5","pages":"e70061"},"PeriodicalIF":1.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13129628/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147764850","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":"The Work Behind the First Dose: How Early Clinical Studies Shape the Course of Drug Development.","authors":"Amalia M Issa","doi":"10.1002/cpdd.70064","DOIUrl":"https://doi.org/10.1002/cpdd.70064","url":null,"abstract":"","PeriodicalId":10495,"journal":{"name":"Clinical Pharmacology in Drug Development","volume":"15 5","pages":"e70064"},"PeriodicalIF":1.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147764755","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":"Comparative Pharmacokinetics and Bioequivalence Assessment of Metformin/Pioglitazone Tablet in Fasting and Fed Conditions: A Randomized Study in Healthy Chinese Subjects.","authors":"Hongcheng Li, Mengke Li, Bin Liu, Zijie Wei, Lulu Chen, Chao Li, Qing Fang, Xintong Wang, Ling Zhou, Dongsheng Ouyang, Xiaohui Li","doi":"10.1002/cpdd.70063","DOIUrl":"https://doi.org/10.1002/cpdd.70063","url":null,"abstract":"<p><p>Metformin/pioglitazone tablets are a fixed-dose combination of metformin hydrochloride and pioglitazone. In healthy Chinese subjects, this study evaluated the pharmacokinetics and bioequivalence of metformin/pioglitazone (500/15 mg) tablets. We conducted a single-center, open-label, randomized, two-way crossover study in which subjects were randomized in a 1:1 ratio to either the test formulation or the reference formulation, separated by a 10-day washout period. Blood samples collected at pre-arranged intervals before and after dosing were analyzed using validated liquid chromatography-tandem mass spectrometry techniques to determine metformin and pioglitazone plasma concentrations. Finally, subjects completed fasting and fed studies, respectively. In both studies, the 90% confidence intervals for the geometric mean ratios (test/reference) of C_max, AUC_0-t, and AUC_0-∞ were within acceptable bioequivalence limits (0.80-1.25), and no serious adverse events were observed. The study demonstrated that the tested and reference formulations of metformin/pioglitazone tablets are bioequivalent and well tolerated under both fasting and fed conditions.</p>","PeriodicalId":10495,"journal":{"name":"Clinical Pharmacology in Drug Development","volume":"15 5","pages":"e70063"},"PeriodicalIF":1.8,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147764840","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, Bioequivalence, and Safety Evaluation of Two Voriconazole Tablets in Healthy Chinese Volunteers","authors":"Pan Luo,&nbsp;Yongfang Lei,&nbsp;Chang Liu,&nbsp;Juan Du,&nbsp;Xiangxiao Deng,&nbsp;Hengyi Yu,&nbsp;Xingxing Qi,&nbsp;Zheng He,&nbsp;Dongling Zhang,&nbsp;Qin Zuo,&nbsp;Yinian Fang,&nbsp;Dong Liu,&nbsp;Qian Chen,&nbsp;Xiuhua Ren","doi":"10.1002/cpdd.70058","DOIUrl":"10.1002/cpdd.70058","url":null,"abstract":"<p>Voriconazole is a broad-spectrum antifungal agent belonging to the triazole class, exhibiting significant efficacy against a diverse array of pathogenic organisms. This study aimed to assess the pharmacokinetic properties, bioequivalence, and safety profiles of two oral formulations of voriconazole tablets. An open-label, randomized, two-period, two-sequence crossover, Phase I bioequivalence trial was conducted involving healthy Chinese volunteers under fasting conditions. During each study period, participants were administered a single 200 mg dose of either the generic (test) or branded (reference) voriconazole tablet, with treatment sequences assigned randomly. Blood samples were collected at various time points before and after administration to determine plasma voriconazole concentrations. The study assessed bioequivalence by calculating the maximum concentration (C_max) and the area under the concentration–time curve (AUC). Adverse events (AEs) were systematically documented. A total of seventy healthy volunteers were recruited, with 68 participants who received voriconazole included in the final analysis. The geometric mean ratios (GMR) of the test tablet to the reference for C_max, the area under the concentration curve from time 0 to the last measurable time point (AUC_0–t), and the area under the concentration curve from time 0 extrapolated to infinity (AUC_0–inf) were determined to be 1.03, 0.98, and 0.97, respectively, under fasting conditions. These values met the established criteria for bioequivalence acceptance. Furthermore, both the test and reference formulations of voriconazole were well tolerated. The findings indicate that the test and reference voriconazole tablets are bioequivalent and possess similar safety profiles in healthy Chinese volunteers.</p>","PeriodicalId":10495,"journal":{"name":"Clinical Pharmacology in Drug Development","volume":"15 4","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147644421","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 Randomized, Double-Blinded, Placebo-Controlled QTc Study to Evaluate BIA 28–6156 Effect on Cardiac Repolarization in Healthy Volunteers","authors":"Isa Peixoto,&nbsp;Dana Hilt,&nbsp;Teresa Carvalho,&nbsp;João Reis,&nbsp;Helena Gama,&nbsp;Joerg Holenz","doi":"10.1002/cpdd.70055","DOIUrl":"10.1002/cpdd.70055","url":null,"abstract":"<p>Mutations in the <i>GBA1</i> gene, encoding beta-glucocerebrosidase (GCase), are the most common genetic risk factor for Parkinson's Disease (PD). BIA 28–6156, an allosteric activator of GCase, is under development for the treatment of GBA-associated PD. This Phase 1, randomized, double-blind, placebo-controlled, crossover study assessed the impact of BIA 28–6156 on QT interval corrected (QTc) for heart rate (HR) based on the Fridericia correction (QTcF) in 37 healthy subjects. Participants received single doses of 60 or 150 mg BIA 28–6156, 400 mg moxifloxacin, or placebo in a cross-over design. The relationship between BIA 28–6156 plasma levels and QTcF changes (ΔQTcF) was analyzed to exclude a ΔΔQTcF &gt; 10 ms. Heart rate, PR, and QRS intervals, electrocardiogram (ECG) waveform morphology, and adverse events (AEs) were also evaluated. The concentration-QTc analysis indicated no effect on ΔΔQTcF exceeding 10 ms up to BIA 28–6156 plasma levels of ≈7150 ng/mL. No clinically significant effects on ECG parameters were observed, and BIA 28–6156 was generally well tolerated, with no deaths or serious AEs. This study concluded that BIA 28–6156 has no clinically relevant impact on ECG parameters, confirming a negative thorough QT/QTc study.</p>","PeriodicalId":10495,"journal":{"name":"Clinical Pharmacology in Drug Development","volume":"15 4","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13065933/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147644462","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":"Steady-State Pharmacokinetic Properties of TNX-102 SL, a Sublingual Tablet Formulation of Cyclobenzaprine Hydrochloride (HCl), With Daily Dosing in Healthy Volunteers: A Randomized, Open-Label Trial","authors":"Gregory M. Sullivan,&nbsp;Bernd Meibohm,&nbsp;Errol Gould,&nbsp;Bruce L. Daugherty,&nbsp;Seth Lederman","doi":"10.1002/cpdd.70060","DOIUrl":"10.1002/cpdd.70060","url":null,"abstract":"<p>This single-center, open-label, randomized, multiple-dose, pharmacokinetic bridging study was conducted to compare systemic exposure (AUC and C_max) of a sublingual tablet formulation of cyclobenzaprine hydrochloride (TNX-102 SL, approved as TONMYA) at steady-state with that of an approved reference product, an oral, extended-release (ER) capsule formulation, supporting development under the 505(b)(2) regulatory pathway. Healthy adults (N = 60) were randomly assigned 1:1 to receive two sublingual 2.8-mg tablets or one oral ER 30-mg capsule once daily for 20 days. At steady state, 2 sublingual 2.8 mg tablets provided lower exposure to cyclobenzaprine and norcyclobenzaprine compared with one oral 30-mg ER capsule. However, when exposures were normalized by dose, cyclobenzaprine AUC_0-24 and C_max were higher on both Day 1 and Day 20 with two sublingual tablets versus one oral ER capsule, supporting higher bioavailability of the sublingual tablet formulation. For Day 20, the dose-normalized ratios (two sublingual tablets: one oral ER capsule) for AUC_{0-τ ss} and C_{max ss} were 140% and 152%, respectively. Sublingual tablets and oral ER capsules had comparable metabolic profiles of Phase I and II metabolites in plasma over 20 days, with no unique metabolites by the sublingual route. Sublingual cyclobenzaprine HCl tablets were generally safe and well-tolerated.</p>","PeriodicalId":10495,"journal":{"name":"Clinical Pharmacology in Drug Development","volume":"15 4","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13058771/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147632714","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":"Bioequivalence and Safety Assessment of Brivaracetam Dry Syrup Compared With Tablets in Healthy Japanese Participants: Results From Two Randomized Single- and Multiple-Dose Trials.","authors":"Yoshinobu Hayakawa, Ryoji Yoshinaka, Tomonobu Sano, Walter Krauwinkel, Tadaharu Soma, Hiroshi Sasamoto, Jan-Peer Elshoff, Almasa Bass, Ying Chen, Nozomi Kurihara, Harumi Murakami","doi":"10.1002/cpdd.70057","DOIUrl":"10.1002/cpdd.70057","url":null,"abstract":"<p><p>The antiseizure medication brivaracetam is available as tablets, oral solution, and solution for intravenous injection in many countries. A dry syrup formulation is being developed for use in Japan. We report two phase 1, single-center, open-label, randomized, two-way crossover trials that assessed bioequivalence, safety, and tolerability of brivaracetam dry syrup and tablet formulations in healthy adult male Japanese participants. EP0110 (NCT05315947) assessed brivaracetam 50 mg dry syrup versus tablet after a single administration (N = 24). Although pharmacokinetic profiles were similar and bioequivalence criteria for AUC were met, bioequivalence criteria for the observed C_max were not met in this trial. A subsequent simulation of parameters at steady state, based on EP0110 data, indicated that bioequivalence could be established in a multiple-dose setting. EP0231 (NCT06312566) was designed employing a group sequential design (N = 96) and assessed brivaracetam 50 mg dry syrup versus tablet after multiple oral doses (N = 64). The point estimates (92.016% CIs) for C_max and AUC at steady state fell within the acceptable range for bioequivalence (0.80-1.25). Bioequivalence of dry syrup and tablet formulations was demonstrated after multiple doses. Single and multiple doses of brivaracetam 50 mg administered as dry syrup or tablet formulation were generally safe and well tolerated in healthy Japanese participants.</p>","PeriodicalId":10495,"journal":{"name":"Clinical Pharmacology in Drug Development","volume":"15 4","pages":"e70057"},"PeriodicalIF":1.8,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13090423/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147715971","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":"Are We Overstudying Biosimilars? Re-Centering Clinical Pharmacology in the Demonstration of Similarity","authors":"Amalia M. Issa","doi":"10.1002/cpdd.70051","DOIUrl":"10.1002/cpdd.70051","url":null,"abstract":"&lt;p&gt;The biosimilar regulatory framework codified by agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) emphasizes a “totality of the evidence” approach encompassing analytical, nonclinical, and clinical comparability steps.&lt;span&gt;&lt;sup&gt;1-3&lt;/sup&gt;&lt;/span&gt; While biosimilars are biologics highly similar to licensed reference products, demonstrating similarity requires evidence that no clinically meaningful differences exist in safety or effectiveness.&lt;span&gt;&lt;sup&gt;4&lt;/sup&gt;&lt;/span&gt; Historically, this has included comparative clinical efficacy trials, especially for complex products where functional biomarkers are unavailable. However, advances in analytical characterization and experience with biosimilar approvals have significantly strengthened the ability of pharmacokinetic and pharmacodynamic (PK/PD) and immunogenicity studies to detect differences, bringing the value of routine large efficacy trials into question.&lt;span&gt;&lt;sup&gt;2, 5&lt;/sup&gt;&lt;/span&gt;&lt;/p&gt;&lt;p&gt;Clinical pharmacology, particularly comparative pharmacokinetic (PK) studies, offers a direct quantitative assessment of exposure that is highly sensitive compared to many clinical endpoints. FDA guidance has noted that demonstration of similar PK profiles between biosimilar and reference products is often sufficient to support similarity without extensive efficacy testing.&lt;span&gt;&lt;sup&gt;2&lt;/sup&gt;&lt;/span&gt; Comparative studies in healthy participants or sensitive patient populations can be designed with rigorous equivalence margins, reducing variability and enhancing discrimination. The use of PD biomarkers, when mechanistically relevant, further enhances sensitivity.&lt;span&gt;&lt;sup&gt;5, 6&lt;/sup&gt;&lt;/span&gt;&lt;/p&gt;&lt;p&gt;The integration of immunogenicity assessment into clinical pharmacology programs is critical, as anti-drug antibodies can influence both PK and clinical outcomes.&lt;span&gt;&lt;sup&gt;1&lt;/sup&gt;&lt;/span&gt; These assessments provide longitudinal insight into safety and efficacy risks beyond structural similarity. The collective evidence from PK, PD, and immunogenicity thus constitutes a scientifically robust clinical pharmacology package that often outweighs the incremental information from large comparative efficacy trials.&lt;/p&gt;&lt;p&gt;Comparative efficacy trials are resource intensive and often statistically underpowered to detect subtle differences, especially in heterogeneous disease populations. Historical experience demonstrates that no approved biosimilar with robust analytical similarity has subsequently failed a comparative clinical efficacy study, underscoring limited incremental value.&lt;span&gt;&lt;sup&gt;6, 7&lt;/sup&gt;&lt;/span&gt; Indeed, a recent detailed review suggests that when analytical similarity and PK equivalence are established, comparative efficacy studies rarely add value and can be waived without compromising regulatory standards.&lt;span&gt;&lt;sup&gt;8&lt;/sup&gt;&lt;/span&gt;&lt;/p&gt;&lt;p&gt;Real-world evidence from post-launch studies shows comparable effectiveness and safety between biosimilars and reference biologics across","PeriodicalId":10495,"journal":{"name":"Clinical Pharmacology in Drug Development","volume":"15 4","pages":""},"PeriodicalIF":1.8,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://accp1.onlinelibrary.wiley.com/doi/epdf/10.1002/cpdd.70051","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147590382","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":"Effects of Cedirogant on the Pharmacokinetics of Sensitive Cytochrome P450 Probe Substrates.","authors":"Ronilda D'Cunha, Yuli Qian, Shuai Hao, Jason Eccleston, Gweneth F Levy, Shashikanth Gannu, David G Rizzo, Wei Liu, Mohamed-Eslam F Mohamed","doi":"10.1002/cpdd.70059","DOIUrl":"10.1002/cpdd.70059","url":null,"abstract":"<p><p>This study aimed to characterize the effects of cedirogant, an inverse agonist of retinoic acid-related orphan receptor gamma thymus (RORγt), on activities of cytochrome P450 (CYP) enzymes in healthy adults. Twenty study participants received a single oral dose of the modified Cooperstown 5+1 cocktail CYP probe drugs alone without cedirogant (Period 1, midazolam on Day 1 and other CYP substrates on Day 2), and again following once-daily dosing of 375 mg cedirogant (Period 2, cedirogant on Days 1-18, midazolam on Day 13, and other CYP substrates on Day 14). Blood samples and 12-hour urine samples were collected to measure the exposures of the CYP probe drugs and selected metabolites. The point estimates (90% confidence intervals) of the area under the plasma concentration-time curve from time 0 to infinity (AUC_inf) ratio with and without cedirogant co-administration were 0.370 (0.325-0.420) for midazolam (CYP3A), 1.161 (1.031-1.307) for caffeine (CYP1A2), and 0.788 (0.761-0.816) for S-Warfarin (CYP2C9). The estimated ratios of plasma metabolite/parent AUC ratio for omeprazole (CYP2C19) and parent/metabolite molar urine recovery ratio for dextromethorphan (CYP2D6) with versus without cedirogant co-administration were 2.115 (1.813-2.467) and 0.951 (0.802-1.128), respectively. Based on these findings, once-daily administration of 375-mg cedirogant showed moderate induction of CYP3A and CYP2C19, a weak effect on CYP2C9, and no clinically relevant effects on CYP1A2 or CYP2D6.</p>","PeriodicalId":10495,"journal":{"name":"Clinical Pharmacology in Drug Development","volume":"15 4","pages":"e70059"},"PeriodicalIF":1.8,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13092883/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147721902","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}