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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05064800
Other study ID # C4671012
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 21, 2021
Est. completion date December 6, 2021

Study information

Verified date January 2022
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date December 6, 2021
Est. primary completion date December 6, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Dabigatran
A single dose of Dabigatran on Day 1
PF-07321332/ritonavir + Dabigatran
PF-07321332/ritonavir twice daily (BID) for Days 1 and 2 Single dose of Dabigatran on Day 2
Ritonavir + Dabigatran
Ritonavir BID on Days 1 and 2 Single dose of Dabigatran on Day 2

Locations

Country Name City State
United States Research Centers of America ( Hollywood ) Hollywood Florida

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Treatments A, B and C; through study completion of approximately 1.5 months
Secondary 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
Secondary 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
Secondary Number of Participants With Abnormalities in Physical Examination Treatment A, B, and C; through study completion of approximately 1.5 months
Secondary Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings Treatment A, B, and C; through study completion of approximately 1.5 months
Secondary 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
Secondary 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
Secondary Cmax of PF-07321332 Treatments A, B, C: pre-dose and 1, 2, 4, 6, 8, 12, 16, 24, and 48 hours post-dose
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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