CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
PF-07321332/ritonavir +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.

Search/NCT04962230
NCT04962230Phase 1Completed
CompareCT.gov

A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD CROSSOVER STUDY TO ESTIMATE THE EFFECT OF CARBAMAZEPINE ON THE PHARMACOKINETICS OF PF-07321332 BOOSTED WITH RITONAVIR IN HEALTHY PARTICIPANTS

Pfizer·interventional·Posted Jul 14, 2021·Updated Oct 10, 2023

In Brief

A Phase 1 clinical trial evaluating PF-07321332/ritonavir, Carbamazepine, and 1 other intervention for Healthy Participant. Completed, enrolled 12 participants across 1 site.

Detailed Summary

This is a drug-drug interaction study to assess the effects of a single dose of PF-07321332/ritonavir after multiple dose administrations of carbamazepine. Pharmacokinetic (PK) will be evaluated for PF-07321332 and ritonavir. Carbamazepine is being utilized as a cytochrome P450 3A4 (CYP3A4) inducer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Participant
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedJul 14, 2021
Enrollment StartJul 15, 2021
Primary CompletionOct 9, 2021
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.0 years ago

Interventions

PF-07321332/ritonavirdrug

PF-07321332/ritonavir administered orally as a single dose on Day 1, Period 1

Carbamazepinedrug

In Period 2, Days 1-3, participants will receive low-dose of carbamazepine twice daily (BID), then a titrated mid-dose of carbamazepine BID on Days 4-7, and finally maintaining carbamazepine at the high-dose on Days 8-15.

PF 07321332/ritonavirdrug

In Period 2, Day 14, participants will receive a single dose of PF-07321332/ritonavir orally.