A Study to Compare the Taste and Levels in Blood Plasma of BMS-986165 When Taken as Different Formulations by Healthy Adult Participants

Phase 1

Completed

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

• Registration Number: NCT04305899
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to compare the taste, and the levels in blood plasma of different tablet formulations of BMS-986165 when taken by healthy adults.

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: 2020-03-10
• Study First Submitted QC: 2020-03-10
• Study First Posted: 2020-03-12
• Study Start: 2020-08-31
• Primary Completion: 2020-11-25
• Study Completion: 2020-11-25
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-09
• Last Update Posted: 2021-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations in the opinion of the investigator
• Women and men must agree to follow specific methods of contraception, if applicable

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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, including a history of/or active liver disease
• 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 Group 1	BMS-986165 Tablet formulation 1	-
Treatment Group 9	BMS-986165 Tablet formulation 1	-
Treatment Group 9	BMS-986165 Tablet formulation 2	-
Treatment Group 10	BMS-986165 Tablet formulation 1	-
Treatment Group 10	BMS-986165 Tablet formulation 2	-
Treatment Group 1	BMS-986165 Tablet formulation 2	-
Treatment Group 2	BMS-986165 Tablet formulation 1	-
Treatment Group 2	BMS-986165 Tablet formulation 2	-
Treatment Group 3	BMS-986165 Tablet formulation 1	-
Treatment Group 3	BMS-986165 Tablet formulation 2	-
Treatment Group 4	BMS-986165 Tablet formulation 1	-
Treatment Group 4	BMS-986165 Tablet formulation 2	-
Treatment Group 5	BMS-986165 Tablet formulation 1	-
Treatment Group 5	BMS-986165 Tablet formulation 2	-
Treatment Group 6	BMS-986165 Tablet formulation 1	-
Treatment Group 6	BMS-986165 Tablet formulation 2	-
Treatment Group 7	BMS-986165 Tablet formulation 1	-
Treatment Group 7	BMS-986165 Tablet formulation 2	-
Treatment Group 8	BMS-986165 Tablet formulation 1	-
Treatment Group 8	BMS-986165 Tablet formulation 2	-

Primary Outcome Measures

Name	Time	Method
Maximum concentration (Cmax) in plasma for BMS-986165	Up to 26 days
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T)) in plasma for BMS-986165	Up to 26 days
Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) in plasma for BMS-986165	Up to 26 days

Secondary Outcome Measures

Name	Time	Method
Incidence of clinically significant changes in vital signs: Blood pressure	Up to 68 days
Incidence of Adverse Events (AEs)	Up to 26 days
Incidence of Serious Adverse Events (SAEs)	Up to 98 days
Incidence of clinically significant changes in physical examination findings	Up to 68 days
Incidence of clinically significant changes in vital signs: Weight	Up to 68 days
Incidence of clinically significant changes in vital signs: Body temperature	Up to 68 days
Incidence of clinically significant changes in vital signs: Respiratory rate	Up to 68 days
Incidence of clinically significant changes in vital signs: Heart rate	Up to 68 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters	Up to 68 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests	Up to 68 days
Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests	Up to 68 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests	Up to 68 days

Trial Locations

Locations (1)

PRA Health Sciences - Lenexa; 🇺🇸 Lenexa, Kansas, United States