NCT04962230

Drug-Drug Interaction Study Assessing Effect of Carbamazepine on PF-07321332 Boosted With Ritonavir

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Participant

Interventions

Type	Name	Description
DRUG	PF-07321332/ritonavir	PF-07321332/ritonavir administered orally as a single dose on Day 1, Period 1
DRUG	Carbamazepine	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.
DRUG	PF 07321332/ritonavir	In Period 2, Day 14, participants will receive a single dose of PF-07321332/ritonavir orally.

Timeline

• Start date: 2021-07-15
• Primary completion: 2021-10-09
• Completion: 2021-10-09
• First posted: 2021-07-14
• Last updated: 2023-10-10
• Results posted: 2023-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study