STUDY OF PF-07321332 IN HEALTHY PARTICIPANTS

Phase 1 Completed 70 enrolled Pfizer

RandomizedCrossoverDouble-blindOther

Summary

A Phase 1, double blind, sponsor open, single and multiple ascending dose study to evaluate safety, tolerability and pharmacokinetics of PF-07321332 in healthy participants.

Timeline

Start: 2021-02-11
Primary completion: 2021-09-01
Completion: 2021-09-01

Publications

Singh RSP, Toussi SS, Hackman F, Chan PL, Rao R, Allen R, Van Eyck L, Pawlak S, Kadar EP, Clark F, Shi H, Anderson AS, Binks M, Menon S, Nucci G, Bergman A. Innovative Randomized Phase I Study and Dosing Regimen Selection to Accelerate and Inform Pivotal COVID-19 Trial of Nirmatrelvir. Clin Pharmacol Ther. 2022 Jul;112(1):101-111. doi: 10.1002/cpt.2603. Epub 2022 May 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nirmatrelvir	Small molecule	—	Oral

Indications

No indication recorded.