Healthy Participants Clinical Trial
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
Verified date | January 2022 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
United States | Research Centers of America ( Hollywood ) | Hollywood | Florida |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
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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