PF-07321332/Ritonavir and Ritonavir on Dabigatran Study in Healthy Participants
- Conditions
- Healthy Participants
- Interventions
- Registration Number
- NCT05064800
- Lead Sponsor
- Pfizer
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment B PF-07321332/ritonavir + Dabigatran PF-07321332/ritonavir + Dabigatran Treatment C Ritonavir + Dabigatran Ritonavir + Dabigatran Treatment A Dabigatran Dabigatran only
- Primary Outcome Measures
Name Time Method Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): Maximum Plasma Concentration (Cmax) Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose Cmax was defined as maximum observed plasma concentration.
Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): AUCinf Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose AUCinf was defined as the area under the plasma concentration-time curve from time 0 extrapolated to infinity
Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): AUClast Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose AUClast was defined as area under the plasma concentration time curve from time 0 to the time of the last measurable concentration.
- Secondary Outcome Measures
Name Time Method Number of Participants With Laboratory Test Abnormality (Without Regard to Baseline Abnormality) From pre-dose on Day 1 to Day 3 To determine if there are any clinically significant laboratory abnormalities, the haematological, clinical chemistry (serum) and urinalysis safety tests were assessed against the criteria specified in the sponsor reporting standards. Tests including Ery. Mean Corpuscular Hemoglobin, Eosinophils, Activated Partial Thromboplastin Time, Bilirubin, Fibrinogen, URINE Hemoglobin, Nitrite, and Leukocyte Esterase tests.
Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): AUCinf Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose AUCinf was defined as area under the plasma concentration-time curve from time 0 extrapolated to infinity
Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): AUClast Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose AUClast was defined as area under the plasma concentration time curve from time 0 to the time of the last measurable concentration.
Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): Maximum Plasma Concentration (Cmax) Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose Cmax was defined as maximum observed plasma concentration
Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): Tmax Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose Tmax was defined as time to first occurrence of Cmax.
Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): t½ Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose t½ was defined as terminal half-life of Dabigatran (Total).
Number of Participants With Vital Signs of Potential Clinical Concern From pre-dose on Day 1 to Day 3 Single supine blood pressure and pulse rate tests were assessed against the criteria specified in the sponsor reporting standards.
Plasma PF-07321332 PK Parameters: AUCtau Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose AUCtau was defined as area under the plasma concentration-time profile from time zero to time tau (τ) the dosing interval, where tau=12 hours for twice daily (BID) dosing.
Plasma PF-07321332 PK Parameters: t½ Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose t½ was defined as terminal half-life of PF-07321332.
Plasma PF-07321332 PK Parameters: Vz/F Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose Vz/F was defined as apparent volume of distribution.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs , and TEAEs Leading to Participant Discontinuation From Study From Pre-dose on Day 1 to Day 48 An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.
Number of Participants With ECG Values of Potential Clinical Concern From pre-dose on Day 1 to Day 3 QT interval, QTc, PR, RR, QRS and heart rate tests were assessed against the criteria specified in the sponsor reporting standards.
Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): Time to First Occurrence of Cmax (Tmax) Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose Tmax was defined as time to first occurrence of Cmax
Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): Terminal Half-life (t½) Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose t½ was defined as terminal half-life of Dabigatran (Total) PK Parameters (PF-07321332/ritonavir co-administered with dabigatran.
Plasma PF-07321332 PK Parameters: Cmax Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose Plasma PF-07321332 PK Parameters: CL/F Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose CL/F was defined as apparent clearance of drug from plasma.
Plasma PF-07321332 PK Parameters: Tmax Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose Tmax was defined as time to first occurrence of Cmax.
Trial Locations
- Locations (1)
Research Centers of America ( Hollywood )
🇺🇸Hollywood, Florida, United States