Pharmacokinetics (Drug Levels in Blood) of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: BMS-986165 prototype 2; Drug: BMS-986165 prototype 1; Drug: BMS-986165

• Registration Number: NCT04249284
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to characterize the pharmacokinetics (the way the body absorbs, distributes and eliminates the drug) of BMS 986165 given in the form of various prototypes of solid tablets to healthy participants.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-01-29
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-01-30
• Study Start: 2020-02-06
• Primary Completion: 2020-03-15
• Study Completion: 2020-03-15
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-08
• Last Update Posted: 2020-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• In the opinion of the investigator, a healthy participant is determined by having no clinically significant deviation from normal in medical history, physical examination,electrocardiograms, vital signs, and clinical laboratory determinations.
• Body weight >= 50 kg at screening
• Women and men must agree to follow specific methods of contraception, if applicable

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Exclusion Criteria

• Any major surgery, per investigator's discretion, within 4 weeks of study drug administration
• Inability to tolerate oral medication
• History of allergy to BMS-986165 or related compounds

Other protocol-defined inclusion/exclusion criteria apply

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment C: BMS-986165 prototype 2	BMS-986165 prototype 2	-
Treatment D: BMS-986165 prototype 2	BMS-986165 prototype 2	-
Treatment B: BMS-986165 prototype 1	BMS-986165 prototype 1	-
Treatment A : BMS-986165	BMS-986165	-

Primary Outcome Measures

Name	Time	Method
Maximum concentration (Cmax) for BMS-986165 in plasma	Up to 18 days
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T)) for BMS-986165 in plasma	Up to 18 days
Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) for BMS-986165 in plasma	Up to 18 days

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs)	Up to 23 days
Incidence of Serious Adverse Events (SAEs)	Up to 55 days
Number of clinically significant abnormalities in electrocardiogram (ECG) parameters	Up to 50 days
Number of participants with vital sign abnormalities in body temperature	Up to 50 days
Number of participants with vital sign abnormalities in respiratory rate	Up to 50 days
Number of participants with vital sign abnormalities in heart rate	Up to 50 days
Number of participants with vital sign abnormalities in blood pressure	Up to 50 days
Number of participants with clinical laboratory test abnormalities: Hematology tests	Up to 50 days
Number of participants with clinical laboratory test abnormalities: Clinical chemistry tests	Up to 50 days
Number of participants with clinical laboratory test abnormalities: Urinalysis tests	Up to 50 days

Trial Locations

Locations (1)

Quotient Sciences Miami; 🇺🇸 Miami, Florida, United States