Pharmacokinetics of Nirmatrelvir/Ritonavir after Multiple Administration in a Phase 1, Open-Label Study in Healthy Chinese Adults and Compared with Non-Chinese Participants
Abstract
Background and objectives: Nirmatrelvir (PF-07321332) has demonstrated antiviral activity and an acceptable safety profile in clinical studies. This study aimed to demonstrate the pharmacokinetic (PK) profiles of Chinese participants after administration of nirmatrelvir/ritonavir, and to further evaluate the ethnic differences between different races.
Methods: This Phase 1, open-label, single-site study assessed the PK, safety, and tolerability of nirmatrelvir 300 mg plus ritonavir 100 mg administered twice daily for 10 days in healthy Chinese adults. In total, 14 Chinese participants were enrolled with an age range of 24 to 43 years. Samples were collected after first-dose administration on day 1 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after drug administration) and last-dose administration on day 10 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 h after drug administration) to assess PK parameters after a single dose and multiple doses; pre-dose samples were collected on days 5, 8, and 10 to confirm that steady-state was achieved. All PK samples were assayed with a liquid chromatography-tandem mass spectrometry method to quantify plasma concentration of nirmatrelvir and ritonavir. Study participants were monitored for safety for 28-35 days after the last-dose administration. Adverse events (AEs), clinical safety laboratory tests, vital signs, and 12-lead electrocardiograms were all monitored during study. Results for Chinese participants were compared with results in healthy…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 14 participants or records.
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