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A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED, SINGLE- AND MULTIPLE-DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF 07321332 IN HEALTHY ADULT PARTICIPANTS

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Trial Profile

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED, SINGLE- AND MULTIPLE-DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF 07321332 IN HEALTHY ADULT PARTICIPANTS

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 21 Jul 2022

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At a glance

  • Drugs Nirmatrelvir (Primary) ; Nirmatrelvir+ritonavir (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; First in man; Pharmacokinetics
  • Sponsors Pfizer

Most Recent Events

  • 09 Jun 2022 Results of a part 4 of the 5 part study assessed the metabolism and excretion of unlabeled nirmatrelvir (PF-07321332) within the first-in-human study via a novel application of quantitative fluorine NMR spectroscopy in place of a standard radiolabel ADME published in the Clinical Pharmacology and Therapeutics
  • 07 Apr 2022 Results published in the Clinical Pharmacology and Therapeutics.
  • 18 Mar 2022 Trial design,presented at the 123rd Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics

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