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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 1

Conditions

Healthy Participants

Treatments

Drug: BMS-986165

Study type

Interventional

Funder types

Industry

Identifiers

NCT03739788
2018-003134-33 (EudraCT Number)
IM011-067

Details and patient eligibility

About

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

Enrollment

8 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

8 participants in 1 patient group

BMS-986165
Experimental group
Description:
Oral and intravenous administration
Treatment:
Drug: BMS-986165

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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