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
Abstract
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.
Conditions: Healthy.
Primary outcome: Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs); Part 1: Number of Participants With Laboratory Test Abnormalities; Part 1: Number of Participants With Vital Signs Meeting Pre-Defined Criteria; Part 1: Number of Participants With Electrocardiogram (ECG) Abnormalities; Part 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs); Part 2: Number of Participants With Laboratory Test Abnormalities; Part 2: Number of Participants With Vital Signs Meeting Pre-Defined Criteria; Part 2: Number of Participants With Electrocardiogram (ECG) Abnormalities; Part 3:Ratio Based on Area Under Plasma Concentration Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) and Area Under Concentration-Time Curve From Time 0 Extrapolated to Infinite Time (AUCinf) of Oral Formulation and Suspension; Part 3: Ratio…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 94 participants or records.
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