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Completed

NCT Number: NCT06411730

A Study to Evaluate the Safety, Tolerability, and Drug Levels of Orally Administered BMS-986368 in Healthy Participants, Healthy Elderly Participants, and Healthy Participants of Japanese Ethnicity

The purpose of this study is to evaluate the safety, tolerability, and drug levels of orally administered BMS-986368 in healthy participants, healthy elderly participants, and healthy participants of japanese ethnicity.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Anaheim, California, 92780, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants must be healthy male or non-pregnant and non-nursing female individuals.
  • For Part 2 only, participants must be of Japanese ethnicity (both biological parents are ethnically Japanese).
  • Participants must have a body mass index (BMI) of 18.0 kg/m2 to 33.0 kg/m2, inclusive.
  • Participants must have normal renal function at screening.

Exclusion criteria

  • Participants must not have a personal or first-degree family (individual's parents, siblings, and children) history of clinically significant psychiatric disorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder, panic disorder, generalized anxiety disorder, and obsessive-compulsive disorder.
  • Participants must not have any significant acute or chronic neurological illness (eg, history of intracranial or intraspinal hemorrhage, CNS lesions, recent bacterial or fungal meningitis, etc) as determined by the investigator.
  • Participants must not have a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary (GU) abnormalities/diseases including but not limited to peptic ulcer disease, or significant GI bleeding, pancreatitis, hypokalemia.
  • Participants must not have had a SARS-CoV-2 infection within 2 weeks prior to screening.
  • Participants must not have a history of any significant drug allergy or hypersensitivity (such as anaphylaxis or hepatotoxicity).
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

BMS-986368

Drug

Specified dose on specified days

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 44 days

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to 44 days

  3. Number of participants with vital sign (VS) abnormalities

    Time frame: Up to 21 days

  4. Number of participants with physical examination abnormalities

    Time frame: Up to 21 days

  5. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 21 days

  6. Number of participants with clinical laboratory asssement abnormalities

    Time frame: Up to 21 days

  7. Number of participants with treatment-emergent suicidal ideation and behavior through assessment of Columbia Suicide Severity Rating Scale (C-SSRS)

    Time frame: Up to 21 days

Secondary outcomes

  1. Area under the plasma concentration-time curve (AUC)

    Time frame: Up to 16 days

  2. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 16 days

  3. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to 16 days

  4. Absolute levels of monoacylglycerol lipase (MGLL) enzymatic activities in peripheral blood mononuclear cells (PBMCs)

    Time frame: Up to 21 days

  5. Percent change from baseline for monoacylglycerol lipase (MGLL) enzymatic activities in peripheral blood mononuclear cells (PBMCs)

    Time frame: Up to 21 days

  6. Plasma concentrations of anandamide (AEA)

    Time frame: Up to 21 days

  7. Percent change from baseline of anandamide (AEA)

    Time frame: Up to 21 days

  8. Whole blood concentrations of 2-arachidonoylglycerol (2-AG)

    Time frame: Up to 21 days

  9. Percent change from baseline of 2-arachidonoylglycerol (2-AG)

    Time frame: Up to 21 days

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered BMS-986368 in Healthy Participants, Healthy Elderly Participants, and Healthy Participants of Japanese Ethnicity

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 13, 2024
Registry last updated
Nov 12, 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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