A Study to Investigate the Effects of Sisunatovir on QTc Interval in Healthy Adult Participants.
Status:
Recruiting
Trial end date:
2023-11-13
Target enrollment:
Participant gender:
Summary
The purpose of the study is to investigate the effects of multiple oral doses of sisunatovir
on QTc Interval.
This study is seeking participants who:
- are male or female of 18 years of age or older
- are examined to be healthy All participants will receive Treatment A, B, and C in a
randomized order based on 6 possible sequences. All treatments will be taken by mouth.
Participants assigned to treatment A will receive 5 oral doses of sisunatovir
administered Q12 hours over 3 days in a fed state. Participants assigned to treatment B
will receive 5 oral doses of matching placebo administered Q12 hours over 3 days in a
fed state. Participants assigned to treatment C will receive 4 oral doses of placebo
administered Q12 hours for 2 days followed by a single dose of 400 mg moxifloxacin on
the morning of Day 3.
All participants will remain in the study clinic for 4 days for each treatment, for safety
review, laboratory collections, and to assess how the study medicine affects QTc intervals.
All participants selected in the study will be required to go through a screening period up
to 28 days. A screening period is the time during which a few participants are examined to
see whether they are fit for the study. During this period, the participant's medical history
and past and current medications will be reviewed. A series of tests will also be performed
to see if they are good to be selected for the study. If the participant meets all required
criteria and are interested in continuing, the participant will be brought into the study
clinic to stay overnight for 4 days for each treatment. On day 4, the participant will be
discharged. About 28 to 35 days after discharge following the final treatment, the
participant will be contacted for a follow up visit either in person or by telephone. This is
to check up on how the participant is doing and to conclude the study.