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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05064800
• Other study ID #: C4671012
• Status: Completed
• Phase: Phase 1
• Start date: September 21, 2021
• Est. completion date: December 6, 2021

Study information

• Verified date: October 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Healthy Participants

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	Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): Maximum Plasma Concentration (Cmax)	Cmax was defined as maximum observed plasma concentration.	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
Primary	Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): AUCinf	AUCinf was defined as the area under the plasma concentration-time curve from time 0 extrapolated to infinity	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
Primary	Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): AUClast	AUClast was defined as area under the plasma concentration time curve from time 0 to the time of the last measurable concentration.	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
Secondary	Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): Maximum Plasma Concentration (Cmax)	Cmax was defined as maximum observed plasma concentration	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
Secondary	Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): AUCinf	AUCinf was defined as area under the plasma concentration-time curve from time 0 extrapolated to infinity	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
Secondary	Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): AUClast	AUClast was defined as area under the plasma concentration time curve from time 0 to the time of the last measurable concentration.	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
Secondary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs , and TEAEs Leading to Participant Discontinuation From Study	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.	From Pre-dose on Day 1 to Day 48
Secondary	Number of Participants With Laboratory Test Abnormality (Without Regard to Baseline Abnormality)	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.	From pre-dose on Day 1 to Day 3
Secondary	Number of Participants With Vital Signs of Potential Clinical Concern	Single supine blood pressure and pulse rate tests were assessed against the criteria specified in the sponsor reporting standards.	From pre-dose on Day 1 to Day 3
Secondary	Number of Participants With ECG Values of Potential Clinical Concern	QT interval, QTc, PR, RR, QRS and heart rate tests were assessed against the criteria specified in the sponsor reporting standards.	From pre-dose on Day 1 to Day 3
Secondary	Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): Time to First Occurrence of Cmax (Tmax)	Tmax was defined as time to first occurrence of Cmax	Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose
Secondary	Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): Tmax	Tmax was defined as time to first occurrence of Cmax.	Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose
Secondary	Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): Terminal Half-life (t½)	t½ was defined as terminal half-life of Dabigatran (Total) PK Parameters (PF-07321332/ritonavir co-administered with dabigatran.	Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose
Secondary	Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): t½	t½ was defined as terminal half-life of Dabigatran (Total).	Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose
Secondary	Plasma PF-07321332 PK Parameters: Cmax		Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose
Secondary	Plasma PF-07321332 PK Parameters: AUCtau	AUCtau was defined as area under the plasma concentration-time profile from time zero to time tau (t) the dosing interval, where tau=12 hours for twice daily (BID) dosing.	Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose
Secondary	Plasma PF-07321332 PK Parameters: t½	t½ was defined as terminal half-life of PF-07321332.	Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose
Secondary	Plasma PF-07321332 PK Parameters: Tmax	Tmax was defined as time to first occurrence of Cmax.	Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose
Secondary	Plasma PF-07321332 PK Parameters: CL/F	CL/F was defined as apparent clearance of drug from plasma.	Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose
Secondary	Plasma PF-07321332 PK Parameters: Vz/F	Vz/F was defined as apparent volume of distribution.	Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose

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