NCT06693518

A Study to Learn About if the Study Medicine Called Ibuzatrelvir Changes How the Body Process the Other Medicine Dabigatran Etexilate in Healthy Adults

A PHASE 1, OPEN-LABEL, RANDOMIZED, 2-PERIOD, 2-SEQUENCE, CROSSOVER STUDY TO ESTIMATE THE EFFECT OF IBUZATRELVIR ON THE PHARMACOKINETICS OF DABIGATRAN IN HEALTHY ADULT PARTICIPANTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, open-label, randomized, 2-period, 2-sequence, cross-over study to estimate the effect of ibuzatrelvir on the PK of dabigatran, a P-gp substrate, in healthy adult participants. Participants who discontinue from the study for non-safety reasons may be replaced at the Sponsor's discretion in collaboration with the investigator. Healthy participants will be screened to determine eligibility within 28 days prior to study treatment. Participants will report to the CRU on Period 1 Day -1 in Period 1 and will be required to stay at the CRU until discharge Day 3 in Period 2. This study will consist of two treatments. Treatment A: 150 mg of dabigatran etexilate; Treatment B: ibuzatrelvir 600 mg + 150 mg of dabigatran etexilate. The participants will be fasted overnight for at least 10 hours before administration of study intervention. Serial dabigatran samples will be collected up to 48 hours post-dose in both Period 1 and Period 2. Dosing of dabigatran in Period 1 and 2 will be separated by approximately 72h. A follow-up (which may be a phone call) will be made to participants approximately 28 to 35 days from administration of the final dose of study intervention. Approximately 20 participants will be enrolled in the study. PK samples will be collected for Dabigatran and Ibuzatrelvir as per SOA.

Conditions

• SARS-CoV-2 Infections

Interventions

Type	Name	Description
DRUG	Treatment B	Ibuzatrelvir 600 mg + Dabigatran Etexilate 150 mg
DRUG	Treatment A	Dabigatran Etexilate 150 mg

Timeline

• Start date: 2024-11-22
• Primary completion: 2025-01-15
• Completion: 2025-01-15
• First posted: 2024-11-18
• Last updated: 2025-01-24

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study