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

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

  • Healthy Participants

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