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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Dabigatran; Drug: Ritonavir + Dabigatran; Drug: PF-07321332/ritonavir + Dabigatran

Study type: Interventional

Funder types: Industry

Identifiers

NCT05064800

C4671012

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Treatment A

Active Comparator group

Description:

Dabigatran only

Treatment:

Drug: Dabigatran

Treatment B

Experimental group

Description:

PF-07321332/ritonavir + Dabigatran

Treatment:

Drug: PF-07321332/ritonavir + Dabigatran

Treatment C

Active Comparator group

Description:

Ritonavir + Dabigatran

Treatment:

Drug: Ritonavir + Dabigatran