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Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Body Mass Index (BMI) of 17.5 to 30.5 kg.m2; and a total body weight >50 kg (110 lbs) - Female participants must have a negative pregnancy test

Exclusion Criteria

  • Positive test for SARS-Co-V2 at the time of screening or Day -1 - Active pathological bleeding or risk of bleeding - Positive urine drug test - History of sensitivity to heparin or heparin induced thrombocytopenia - Participants who have been vaccinated for COVID-19 in the past 7 days

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
This is a Phase1, open-label,3-treatment, 6-sequence, 3-period crossover study to estimate the effect of PF-07321332/ritonavir and ritonavir on the Pharmacokinetics of dabigatran in healthy participants
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Treatment A 		Dabigatran only
  • Drug: Dabigatran
    A single dose of Dabigatran on Day 1
Experimental
Treatment B 		PF-07321332/ritonavir + Dabigatran
  • Drug: PF-07321332/ritonavir + Dabigatran
    PF-07321332/ritonavir twice daily (BID) for Days 1 and 2 Single dose of Dabigatran on Day 2
Active Comparator
Treatment C 		Ritonavir + Dabigatran
  • Drug: Ritonavir + Dabigatran
    Ritonavir BID on Days 1 and 2 Single dose of Dabigatran on Day 2

Recruiting Locations

More Details

NCT ID
NCT05064800
Status
Completed
Sponsor
Pfizer

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.