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PF-07321332/Ritonavir and Ritonavir on Dabigatran Study in Healthy Participants

NCT05064800 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-03-29

Study results available
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Summary

This is a drug-drug interaction study to assess the effects of PF-07321332/ritonavir and ritonavir on the Pharmacokinetic (PK) of dabigatran in healthy volunteers. PK will be evaluated for PF-07321332 and ritonavir. Dabigatran is being utilized as a P-gp substrate

Conditions

  • Healthy Participants

Interventions

DRUG

Dabigatran

A single dose of Dabigatran on Day 1

DRUG

PF-07321332/ritonavir + Dabigatran

PF-07321332/ritonavir twice daily (BID) for Days 1 and 2 Single dose of Dabigatran on Day 2

DRUG

Ritonavir + Dabigatran

Ritonavir BID on Days 1 and 2 Single dose of Dabigatran on Day 2

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-21
Primary Completion
2021-12-06
Completion
2021-12-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05064800 on ClinicalTrials.gov