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Completed

NCT Number: NCT06170723

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

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.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Other protocol-defined inclusion/exclusion criteria apply.

Treatment and study plan

BMS-986368

Drug

Specified dose on specified days

Itraconazole

Drug

Specified dose on specified days

Famotidine

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 11 days

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

    Time frame: Up to 11 days

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

    Time frame: Up to 11 days

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 41 days

  2. Number of participants with physical examination abnormalities

    Time frame: Up to 17 days

  3. Number of participants with vital sign abnormalities

    Time frame: Up to 17 days

  4. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 17 days

  5. Number of participants with clinical laboratory abnormalities

    Time frame: Up to 17 days

  6. Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: Up to 17 days

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 14, 2023
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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