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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-21

Study Completion Date

2021-12-06

Brief Summary

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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

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment A

Dabigatran only

Group Type ACTIVE_COMPARATOR

Dabigatran

Intervention Type DRUG

A single dose of Dabigatran on Day 1

Treatment B

PF-07321332/ritonavir + Dabigatran

Group Type EXPERIMENTAL

PF-07321332/ritonavir + Dabigatran

Intervention Type DRUG

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

Treatment C

Ritonavir + Dabigatran

Group Type ACTIVE_COMPARATOR

Ritonavir + Dabigatran

Intervention Type DRUG

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

Interventions

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Dabigatran

A single dose of Dabigatran on Day 1

Intervention Type DRUG

PF-07321332/ritonavir + Dabigatran

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

Intervention Type DRUG

Ritonavir + Dabigatran

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes