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NCT05878522 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Effects of Sisunatovir on QTc Interval in Healthy Adult Participants.
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT05878522: Completed Phase 1 study, sponsored by Pfizer.
NCT05878522 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05878522, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study 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.
Primary Outcome
The relationship between sisunatovir plasma concentration and change from baseline in Fridericia's heart-rate corrected QT interval were analyzed using a model-based concentration-QTc analysis consistent with the Scientific White Paper on Concentration-QT Modeling. Baseline was defined as the mean of the 3 averages of the triplicate electrocardiogram (ECG) measurements taken before dosing on Day 1 within each period. Mean and CI statistics were based on the individual (within subject) corrected
Interventions
- DRUG placebo
- DRUG moxifloxacin
- DRUG sisunatovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2023-05-15 |
| Est. Completion | 2023-10-30 |
| Phase | Phase 1 |
What the finished NCT05878522 record still lists
NCT05878522 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT05878522 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05878522 about?
NCT05878522 is a clinical study titled "A Study to Investigate the Effects of Sisunatovir on QTc Interval in Healthy Adult Participants.". 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 or...
What is the current status of trial NCT05878522?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2023-05-15. Estimated completion is 2023-10-30.
What interventions are being tested in trial NCT05878522?
The interventions under investigation include: placebo (DRUG), moxifloxacin (DRUG), sisunatovir (DRUG).
Who is sponsoring clinical trial NCT05878522?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05878522's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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