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

NCT06170723 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-07-01

No results posted yet for this study

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

DRUG

BMS-986368

Specified dose on specified days

DRUG

Itraconazole

Specified dose on specified days

DRUG

Famotidine

Specified dose on specified days

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-18
Primary Completion
2024-05-25
Completion
2024-05-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06170723 on ClinicalTrials.gov