drugset / Trial / NCT05987072

A Study to Learn How the Study Medicine Called Sisunatovir is Tolerated and Acts in the Bodies of Chinese Healthy Adults.

NCT05987072

Phase 1 Completed 12 enrolled Pfizer
NaSingle-groupOpen-labelOther

Summary

The purpose of the study is to learn about: * The activity of sisunotavir in the body over a period. It includes the processes by which sisunotavir is absorbed, distributed in the body, localized in the tissues, and removed from the body. * safety and tolerability of sisunatovir (PF-07923568) in Chinese healthy adult participants. This information is being collected to support further clinical development as well as medicine registration in China. This study is seeking for participants who: * are male and female participants aged 18 to 65 years of age. * are male and female participants who are healthy as seen by medical tests. * have body mass index (BMI) of 19 to 27 kg/m2 and a total body weight of more than 50 kilograms (110 pounds). About 12 participants will receive sisunatovir. Four capsules (strength=50 milligrams, 200 milligrams in total) of Sisunatovir will be given on Day 1 on empty stomach. This will be followed by 8 capsules of sisunatovir with 12 hours gap in between four capsules from Days 4 to 7. The participants will have to take 4 capsules of sisunatovir in the morning of 8th day with a meal. The total time of participants will be in the study is about 71 days. This includes the screening visit to the Follow-up contact. In screening visit, participants will be tested to see if they are fit to take part in the study.

Timeline

Start
2023-11-03
Primary completion
2023-12-31
Completion
2023-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject sisunatovir Small molecule 200 mg