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A Study to Assess the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on BMS-986278 in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05932303
Recruitment Status : Completed
First Posted : July 6, 2023
Last Update Posted : October 30, 2023
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
This is a study in healthy participants designed to assess the effect of multiple doses of itraconazole, gemfibrozil, or carbamazepine on the drug levels of a single-dose of BMS-986278.

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: BMS-986278 Drug: Itraconazole Drug: Gemfibrozil Drug: Carbamazepine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, 3-arm, Open-label, Sequential Design Study to Investigate the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on Single-dose Pharmacokinetics of BMS-986278 in Healthy Participants
Actual Study Start Date : July 12, 2023
Actual Primary Completion Date : October 23, 2023
Actual Study Completion Date : October 23, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: BMS-986278, followed by itraconazole Drug: BMS-986278
Specified dose on specified days

Drug: Itraconazole
Specified dose on specified days
Experimental: BMS-986278, followed by gemfibrozil Drug: BMS-986278
Specified dose on specified days

Drug: Gemfibrozil
Specified dose on specified days
Experimental: BMS-986278, followed by carbamazepine Drug: BMS-986278
Specified dose on specified days

Drug: Carbamazepine
Specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 33 days ]
  2. Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T]) [ Time Frame: Up to 33 days ]
  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) [ Time Frame: Up to 33 days ]

Secondary Outcome Measures :
  1. Number of participants with adverse events (AEs) [ Time Frame: Up to 33 days ]
  2. Number of participants with physical examination abnormalities [ Time Frame: Up to 33 days ]
  3. Number of participants with vital sign abnormalities [ Time Frame: Up to 33 days ]
  4. Number of participants with electrocardiogram (ECG) abnormalities [ Time Frame: Up to 33 days ]
  5. Number of participants with clinical laboratory abnormalities [ Time Frame: Up to 33 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index (BMI) of 18.0 kilograms per meter squared (kg/m^2) through 32.0 kg/m^2, inclusive.

BMI = weight (kg)/(height [m])2.

  • Body weight ≥ 50 kg for males and ≥ 45 kg for females.

Exclusion Criteria:

  • Any significant acute or chronic medical illness.
  • Any gastrointestinal disease or surgery (including cholecystectomy) or other procedures (for example, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. Note: Appendectomy is allowed.
  • Any major surgery within 4 weeks of study intervention administration.

Other protocol-defined inclusion/exclusion criteria apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05932303


Locations
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Canada, CA
Local Institution - 0001
Québec, CA, Canada, G1P 0A2
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05932303    
Other Study ID Numbers: IM027-1007
First Posted: July 6, 2023    Key Record Dates
Last Update Posted: October 30, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-andresearch/ disclosure-commitment.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
BMS-986278
Itraconazole
Gemfibrozil
 Carbamazepine
Idiopathic pulmonary fibrosis
Drug interaction
Additional relevant MeSH terms:
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Itraconazole
Carbamazepine
Gemfibrozil
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Anticonvulsants
 Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Sodium Channel Blockers
Membrane Transport Modulators
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents