NCT06646042

A Study to Learn If the Study Medicine Called Carbamazepine Changes How the Body Processes the Other Study Medicine Ibuzatrelvir in Healthy Adults

A PHASE 1, OPEN-LABEL, FIXED SEQUENCE STUDY TO ESTIMATE THE EFFECT OF CARBAMAZEPINE ON THE PHARMACOKINETICS OF IBUZATRELVIR IN HEALTHY ADULT PARTICIPANTS

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

Summary

The purpose of this study is to estimate the effect of carbamazepine, a strong CYP3A4 inducer, on the pharmacokinetics (PK) of ibuzatrelvir in healthy participants. This study is seeking participants who: * are male or female that are not of childbearing potential of 18 years of age or older * are examined to be healthy The study will consist of two treatments: (1) a single oral dose of ibuzatrelvir 600 mg alone in Period 1 and (2) carbamazepine q12h (BID) titrated from 100 mg to 300 mg over 15 days with a single ibuzatrelvir 600 mg dose coadministered on day 15 in Period 2. All treatments will be taken by mouth. All participants will remain in the study clinic for 18 days for safety review, laboratory collections, and to collect samples for PK. All participants selected in the study will be required to go through a screening period up to 28 days. A screening period is the time during which a few participants are examined to see whether they are fit for the study. During this period, the participant's medical history and past and current medications will be reviewed. A series of tests will also be performed to see if they are good to be selected for the study. If the participant meets all required criteria and are interested in continuing, the participant will be brought into the study clinic to stay overnight for 18 days. About 28 to 35 days after discharge following the final treatment, the participant will be contacted for a follow up visit either in person or by telephone. This is to check up on how the participant is doing and to conclude the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ibuzatrelvir	2x 300 mg tablet
DRUG	carbamazepine ER	100 mg BID (Day 1-3) 200 mg BID (Day 4-7) 300 mg BID (Day 8-15)

Timeline

• Start date: 2024-10-28
• Primary completion: 2025-01-17
• Completion: 2025-01-17
• First posted: 2024-10-17
• Last updated: 2025-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study