NCT06170723

A Study to Assess the Effects of Itraconazole, Food, and pH on the Drug Levels of BMS-986368 in Healthy Participants

A Phase 1, 2-Part, Open-Label, Fixed-Sequence Study to Evaluate the Effects of Itraconazole, Food, and pH, on the Single Dose Pharmacokinetics of BMS-986368 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This 2-part study will evaluate the effect of coadministration of a Cytochrome P450, family 3, subfamily A (CYP3A) inhibitor, itraconazole (Part 1), and a high-fat/high-calorie meal and a modified gastric pH (Part 2), on the single dose drug levels of BMS-986368 in healthy participants.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	BMS-986368	Specified dose on specified days
DRUG	Itraconazole	Specified dose on specified days
DRUG	Famotidine	Specified dose on specified days

Timeline

• Start date: 2024-03-18
• Primary completion: 2024-05-25
• Completion: 2024-05-25
• First posted: 2023-12-14
• Last updated: 2024-07-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study