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

NCT06170723 | Completed Phase 1 FDA Drug

• 1 other identifier: IM045-1002
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

BMS-986368; Itraconazole; Famotidine; Food Effect; Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Maximum observed plasma concentration (Cmax)

  Up to 11 days

• Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])

  Up to 11 days

• Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])

  Up to 11 days

Secondary Outcomes (6)

• Number of participants with adverse events (AEs)

  Up to 41 days

• Number of participants with physical examination abnormalities

  Up to 17 days

• Number of participants with vital sign abnormalities

  Up to 17 days

• Number of participants with electrocardiogram (ECG) abnormalities

  Up to 17 days

• Number of participants with clinical laboratory abnormalities

  Up to 17 days

Study Arms (6)

Part 1: BMS-986368 - Fasted

EXPERIMENTAL

Drug: BMS-986368

Part 1: Itraconazole - Fasted

EXPERIMENTAL

Drug: Itraconazole

Part 1: BMS-986368 with Itraconazole - Fasted

EXPERIMENTAL

Drug: BMS-986368; Drug: Itraconazole

Part 2: BMS-986368 - Fasted

EXPERIMENTAL

Drug: BMS-986368

Part 2: BMS-986368 - Fed

EXPERIMENTAL

Drug: BMS-986368

Part 2: Famotidine, followed by BMS-986368 - Fasted

EXPERIMENTAL

Drug: BMS-986368; Drug: Famotidine

Interventions

BMS-986368 DRUG

Specified dose on specified days

Part 1: BMS-986368 - Fasted; Part 1: BMS-986368 with Itraconazole - Fasted; Part 2: BMS-986368 - Fasted; Part 2: BMS-986368 - Fed; Part 2: Famotidine, followed by BMS-986368 - Fasted

Itraconazole DRUG

Specified dose on specified days

Part 1: BMS-986368 with Itraconazole - Fasted; Part 1: Itraconazole - Fasted

Famotidine DRUG

Specified dose on specified days

Part 2: Famotidine, followed by BMS-986368 - Fasted

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) of 18.0 kilograms per meter squared (kg/m\^2) to 33.0 kg/m\^2, inclusive.

You may not qualify if:

• Personal or first-degree family history of clinically significant psychiatric disorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder, generalized anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder. Situational depression, or anxiety in the past, may be enrolled at the discretion of the investigator.
• Participant has an active or prior history of stroke, chronic seizures, or major neurological disorders or has first-degree family relative who was diagnosed with these disorders below the age of 65 years.
• Participant has a history of syncope and/or symptomatic orthostatic hypotension in the year prior to Day 1.

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Local Institution - 0001

Tempe, Arizona, 85283, United States

Location

Related Links

• BMS Clinical Trial Information

MeSH Terms

Interventions

Itraconazole; Famotidine

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Thiazoles; Sulfur Compounds; Organic Chemicals

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 14, 2023
• Study Start: March 18, 2024
• Primary Completion: May 25, 2024
• Study Completion: May 25, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

US (1)