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Study to Characterize the Effects of Cytochrome p450 1A2 Inhibition on Systemic Exposure to BMS-986165

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: NCT03930602
Recruitment Status : Completed
First Posted : April 29, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
To compare the pharmacokinetic characteristics of BMS-986165 after a single-dose administration alone vs. in combination with fluvoxamine (CYP1A2 inhibitor)

Condition or disease Intervention/treatment Phase
Healthy Drug: BMS-986165 Drug: Fluvoxamine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open-label, Single-sequence Study to Investigate the Effects of Cytochrome P450 1A2 Inhibition on the Pharmacokinetics of BMS-986165 in Healthy Participants
Actual Study Start Date : May 1, 2019
Actual Primary Completion Date : May 27, 2019
Actual Study Completion Date : May 27, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BMS-986165+Fluvoxamine Drug: BMS-986165
Participants will receive BMS-986165.

Drug: Fluvoxamine
Participants will receive fluvoxamine.

Experimental: BMS-986165 only Drug: BMS-986165
Participants will receive BMS-986165.

Experimental: Fluvoxamine only Drug: Fluvoxamine
Participants will receive fluvoxamine.




Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) of BMS-986165 [ Time Frame: 10 days ]
  2. AUC(0-T) of BMS-986165 [ Time Frame: 10 days ]
  3. AUC(INF) of BMS-986165 [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. Fluvoxamine steady-state plasma concentrations [ Time Frame: 10 days ]
  2. Percentage of participants with Adverse events (AEs) [ Time Frame: From screening up to end of drug treatment (Day 13) ]
  3. Percentage of participants with Serious Adverse events (SAEs) and Death [ Time Frame: From screening up to end of drug treatment (Day 13) ]
  4. Percentage of participants with Adverse events (AEs) leading to discontinutation [ Time Frame: From screening up to end of drug treatment (Day 13) ]
  5. Percentage of participants with clinical significant laboratory abnormalities vital sign measurements and ECGs [ Time Frame: From screening up to end of drug treatment (Day 13) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations in the opinion of the investigator.
  • Body mass index of 18 to 32 kilograms per square meter (kg/m2), inclusive, and body weight ≥ 50 kg, at screening.
  • Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) > 80 milliliter/minute/1.732 meter square calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.

Exclusion Criteria:

  • Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study,
  • Any major surgery within 4 weeks of study drug administration
  • Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1.

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): NCT03930602


Locations
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United States, Utah
PRA Health Sciences
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03930602    
Other Study ID Numbers: IM011-088
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fluvoxamine
BMS-986165
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Dermatologic Agents
Protein Kinase Inhibitors