An Investigational Study to Evaluate Experimental Medication BMS-986165 Given as a Tablet and Solution in Healthy Male Participants

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: BMS-986165

• Registration Number: NCT03739788
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to investigate BMS-986165 given as a tablet in healthy male 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: 2018-11-09
• Study First Submitted QC: 2018-11-13
• Study First Posted: 2018-11-14
• Study Start: 2018-12-05
• Primary Completion: 2019-02-11
• Study Completion: 2019-02-11
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

• Healthy male participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
• Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and total body weight ≥ 50 kg (110 lb). BMI = weight (kg)/(height [m])2 at screening
• Normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) ≥ 80 mL/min/1.732

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Exclusion Criteria

• Any 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
• Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
• History or presence of clinically significant acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening

Other protocol defined inclusion/exclusion criteria could apply

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMS-986165	BMS-986165	Oral and intravenous administration

Primary Outcome Measures

Name	Time	Method
Absolute oral bioavailability (F) of BMS-986165 derived from plasma concentration versus time data	4 days

Secondary Outcome Measures

Name	Time	Method
Incidence of nonserious adverse events (AE)	Up to 34 days
Number of clinically significant changes in ECG, vital signs, physical examination findings, or clinical laboratory tests	Up to 34 days
Incidence of serious adverse events (SAE)	Up to 34 days

Trial Locations

Locations (1)

Quotient Sciences; 🇬🇧 Nottingham, United Kingdom