NCT04956627

A Study to Assess the Effect of Itraconazole, Phenytoin and Gemfibrozil on the Drug Levels of BMS-986166 in Healthy Participants

A Phase 1, Single-Center, Parallel-Group, Open-Label, Randomized, Drug-Drug Interaction Study to Assess the Effect of Itraconazole, Phenytoin, and Gemfibrozil on the Pharmacokinetics of a Single Oral Dose of BMS-986166 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effect of itraconazole, phenytoin and gemfibrozil on the drug levels of BMS-986166 and its active metabolite BMT-121795. Participants will be randomly assigned to one of four groups and will remain in the study clinic for the duration of treatment.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	BMS-986166	Specified dose on specified days
DRUG	Itraconazole	Specified dose on specified days
DRUG	Extended Phenytoin Sodium	Specified dose on specified days
DRUG	Gemfibrozil	Specified dose on specified days

Timeline

• Start date: 2021-07-28
• Primary completion: 2022-04-27
• Completion: 2022-04-27
• First posted: 2021-07-09
• Last updated: 2022-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study