A Phase 1, Randomized, Placebo-Controlled, Multiple-Dose, Double-Blind Study to Evaluate and Compare the Pharmacokinetics and Safety of Rimegepant in Healthy Adult Japanese and Caucasian Individuals
Abstract
This Phase 1, randomized, placebo-controlled, double-blind study assessed the pharmacokinetic profile of rimegepant (25, 75, or 150 mg once daily for 14 days) in healthy Japanese and Caucasian adults. Exposures were modestly increased in Japanese participants compared with Caucasian participants following a single dose of rimegepant (Day 1); fold-change (expressed as geometric mean ratio) for Japanese versus Caucasian participants ranged 1.13-1.55 for maximum plasma concentration (Cmax) and 1.22-1.48 for area under the concentration-time curve to one dosing interval (AUCtau) across all doses. Generally, rimegepant exposures were also similar or slightly higher in Japanese participants compared with Caucasian participants at steady state (Day 14); fold-change for Japanese versus Caucasian participants ranged 0.97-1.30 for Cmax,ss and 1.10-1.38 for AUCtau,ss across all doses. Analysis of dose-normalized exposures confirmed higher rimegepant exposure in Japanese participants than Caucasian participants. These effects were due to differences in body weight in Japanese and Caucasian participants since post hoc analyses, where exposure parameters were normalized to body weight and to a 75-mg dose of rimegepant, showed that differences in Cmax and AUCtau between the ethnic groups were <20% following a single dose (Day 1) and <5% at steady state (Day 14). Greater than dose-proportional increases in rimegepant exposure were observed in both Japanese and Caucasian participants.…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
Read the paper
Related studies
- Calcium Ions in the Physiology and Pathology of the Central Nervous System
- AI-powered in silico twins: redefining precision medicine through simulation, personalization, and predictive healthcare
- In silico functional, structural and pathogenicity analysis of missense single nucleotide polymorphisms in human MCM6 gene
- In Silico drug repurposing pipeline using deep learning and structure based approaches in epilepsy
- Targeting serotonin receptors with phytochemicals – an in-silico study
- In silico exploration of anti-prostate cancer compounds from differential expressed genes
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.