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Completed

NCT Number: NCT03739788

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

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

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Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences

Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986165

Drug

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

Primary outcomes

  1. Absolute oral bioavailability (F) of BMS-986165 derived from plasma concentration versus time data

    Time frame: 4 days

Secondary outcomes

  1. Incidence of nonserious adverse events (AE)

    Time frame: Up to 34 days

  2. Incidence of serious adverse events (SAE)

    Time frame: Up to 34 days

  3. Number of clinically significant changes in ECG, vital signs, physical examination findings, or clinical laboratory tests

    Time frame: Up to 34 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Study to Evaluate the Absolute Bioavailability of BMS-986165 Tablet in Healthy Male Participants

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 14, 2018
Registry last updated
Feb 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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