Trials / Completed
CompletedNCT05580003
A Study to Learn Safety and Blood Levels of PF-07817883 in Healthy People
COVID-19: A MULTIPART, PHASE 1 STUDY WITH RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, SINGLE- AND MULTIPLE-DOSE ESCALATION TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-07817883 AND OPTIONAL OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE RELATIVE BIOAVAILABILITY AND FOOD EFFECT OF SOLID ORAL FORMULATION AND OPTIONAL OPEN-LABEL, NON-RANDOMIZED STUDY TO EVALUATE METABOLISM AND EXCRETION OF PF-07817883 AND OPTIONAL RANDOMIZED, OPEN-LABEL STUDY TO ASSESS THE EFFECT OF PF-07817883 ON PHARMACOKINETICS OF MIDAZOLAM IN HEALTHY ADULT PARTICIPANTS
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 94 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this clinical trial is to learn if the study medicine (called PF-07817883) is safe and how it goes in and out of the body in healthy people. PF-07817883 is for the potential treatment of COVID-19. Participants will take PF-07817883 by mouth up to 2 times a day. This study may also evaluate how much PF-07817883 gets into the body when taken as pill. We may study if people's diets can affect this study medicine. We may also examine how PF-07817883 is processed and removed by the human body. Finally, we may look into if PF-07817883 has potential to interact with midazolam.
Detailed description
Combined 6-part study. Part-1: Single Ascending dose Part-2: Multiple Ascending Dose Part-3: Relative bioavailability and food effect Part-4: Metabolism and Excretion Part-5: Drug-drug interaction with midazolam Part-6: Supratherapeutic exposure Part-1,2 and 6 are double blind, sponsor open and Part-3,4 and 5 are open label study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PF-07817883 | Oral suspension or solid oral formulation(s) |
| DRUG | Placebo | Placebo suspension |
| DRUG | Midazolam | midazolam oral solution |
| DRUG | Moxifloxacin | Moxifloxacin 400 mg tablet |
Timeline
- Start date
- 2022-10-17
- Primary completion
- 2023-09-15
- Completion
- 2023-09-15
- First posted
- 2022-10-14
- Last updated
- 2024-11-21
- Results posted
- 2024-11-21
Locations
2 sites across 2 countries: United States, Belgium
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05580003. Inclusion in this directory is not an endorsement.