At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Dabigatran +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Dabigatran, PF-07321332/ritonavir + Dabigatran, and 1 other intervention for Healthy Participants. Completed, enrolled 24 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Participants
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
Enrollment StartSep 2021
First PostedOct 2021
Primary CompletionDec 2021
TodayJul 2026
First PostedOct 1, 2021
Enrollment StartSep 21, 2021
Primary CompletionDec 6, 2021
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 4.8 years ago
Interventions
Dabigatrandrug
A single dose of Dabigatran on Day 1
PF-07321332/ritonavir + Dabigatrandrug
PF-07321332/ritonavir twice daily (BID) for Days 1 and 2 Single dose of Dabigatran on Day 2
Ritonavir + Dabigatrandrug
Ritonavir BID on Days 1 and 2 Single dose of Dabigatran on Day 2