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

NCT ID: NCT03739788

Last Updated: 2021-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-05

Study Completion Date

2019-02-11

Brief Summary

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The purpose of this study is to investigate BMS-986165 given as a tablet in healthy male participants.

Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BMS-986165

Oral and intravenous administration

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Oral administration of tablet and 15-minute intravenous BMS-986165 solution for infusion

Interventions

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BMS-986165

Oral administration of tablet and 15-minute intravenous BMS-986165 solution for infusion

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Quotient Sciences

Nottingham, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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Other Identifiers

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2018-003134-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IM011-067

Identifier Type: -

Identifier Source: org_study_id

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