Phase 1 N=24 Basic Science

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

Healthy Participants

Bottom Line

View on ClinicalTrials.gov: NCT05064800 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2024

Primary outcome: Primary: Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): Maximum Plasma Concentration (Cmax) — 71.87; 154.1 ng/mL

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Dabigatran (Drug); PF-07321332/ritonavir + Dabigatran (Drug); Ritonavir + Dabigatran (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Dec 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): Maximum Plasma Concentration (Cmax)	71.87; 154.1	—
PRIMARY Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): AUCinf	625.6; 1177	—
PRIMARY Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): AUClast	595.0; 1178	—
SECONDARY Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): Maximum Plasma Concentration (Cmax)	71.87; 117.9	—
SECONDARY Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): AUCinf	625.6; 1079	—
SECONDARY Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): AUClast	595.0; 909.3	—
SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs , and TEAEs Leading to Participant Discontinuation From Study	3; 5; 2; 0; 2; 1	—
SECONDARY Number of Participants With Laboratory Test Abnormality (Without Regard to Baseline Abnormality)	1; 1; 1; 1; 1; 0	—
SECONDARY Number of Participants With Vital Signs of Potential Clinical Concern	2; 2; 0; 0; 2; 0	—
SECONDARY Number of Participants With ECG Values of Potential Clinical Concern	0; 0; 0; 1; 0; 0	—
SECONDARY Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): Time to First Occurrence of Cmax (Tmax)	2.000	—
SECONDARY Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): Tmax	2.000	—
SECONDARY Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): Terminal Half-life (t½)	9.636	—
SECONDARY Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): t½	10.16	—
SECONDARY Plasma PF-07321332 PK Parameters: Cmax	4065	—
SECONDARY Plasma PF-07321332 PK Parameters: AUCtau	30080	—
SECONDARY Plasma PF-07321332 PK Parameters: t½	3.969	—
SECONDARY Plasma PF-07321332 PK Parameters: Tmax	2.000	—
SECONDARY Plasma PF-07321332 PK Parameters: CL/F	9.975	—
SECONDARY Plasma PF-07321332 PK Parameters: Vz/F	56.48	—

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05064800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.