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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT05064800

Collaborator

(none)

Enrollment

Location

Arms

2.5

Actual Duration (Months)

9.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: Dabigatran Drug: PF-07321332/ritonavir + Dabigatran Drug: Ritonavir + Dabigatran	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

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 participantsThis 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

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

A PHASE 1, 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

Actual Study Start Date :

Sep 21, 2021

Actual Primary Completion Date :

Dec 6, 2021

Actual Study Completion Date :

Dec 6, 2021

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Area under the curve from time zero to infinity (AUCinf) of dabigatran when administer with PF-07321332/ritonavir [Treatment A; pre-dose, and 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose]
Maximum Observed Plasma Concentration (Cmax) of dabigatran when administered with PF-07321332/ritonavir [Treatment A; pre-dose, and 1, 2, 4, 6, 8, 12, 16, 24, and 48 hours post-dose]

Secondary Outcome Measures

AUCinf of dabigatran when administered with multiple doses of ritonavir [Treatment C; Pre-dose and 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose]
Cmax of dabigatran when administered with multiple doses of ritonavir [Treatment C; pre-dose and 1, 2, 4, 6, 8, 12, 16, 24, and 48 hours post-dose]
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Treatments A, B and C; through study completion of approximately 1.5 months]
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities [Treatments A, B, and C; through study completion of approximately 1.5 months]
Number of Participants With Clinically Significant Change From Baseline in Vital Signs [Treatment A, B, and C; through study completion of approximately 1.5 months]
Number of Participants With Abnormalities in Physical Examination [Treatment A, B, and C; through study completion of approximately 1.5 months]
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings [Treatment A, B, and C; through study completion of approximately 1.5 months]
Time to Reach Maximum Observed Plasma Concentration (Tmax) of dabigatran [Treatments A, B and C; Pre-dose and 1, 2, 4, 6, 8, 12, 16, 24, and 48 hours]
Plasma Decay Half-Life (t1/2) of dabigatran [Treatments A, B and C; pre-dose and 1, 2, 4, 6, 8, 12, 16, 24, and 48 hours post-dose]
Cmax of PF-07321332 [Treatments A, B, C: pre-dose and 1, 2, 4, 6, 8, 12, 16, 24, and 48 hours post-dose]
AUCtau (area under the curve of the dosing interval) of PF-0321332 [Treatments A, B and C: pre-dose and 1, 2, 4, 6, 8, 12, 16, 24, and 48 hours post-dose]
Tmax of PF-0321332 [Treatments A, B and C: pre-dose and 1, 2, 4, 6, 8, 12, 16, 24, and 48 hours post-dose]
T1/2 of PF-0321332 [Treatments A, B and C: pre-dose and 1, 2, 4, 6, 8, 12, 16, 24, and 48 hours post-dose]
Apparent Oral Clearance (CL/F) of PF-0321332 [Treatments A, B and C: pre-dose and 1, 2, 4, 6, 8, 12, 16, 24, and 48 hours post-dose]
Apparent Volume of Distribution (Vz/F) of PF-0321332 [Treatments A, B and C: pre-dose and 1, 2, 4, 6, 8, 12, 16, 24, and 48 hours post-dose]