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OpenTrials
Completed

NCT Number: NCT03660436

An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants

The purpose of this study is to investigate the effects of experimental medication BMS-986165 in healthy male participants.

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Key information

Conditions

Healthy Participants

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences

Salt Lake City, Utah, 84107, United States

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 participant, as determined by no clinically significant deviation from normal in physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
  • Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
  • Normal renal function at screening as evidenced by an estimated GFR (glomerular filtration rate) > 80 mL/min/1.732 m2

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
  • Positive anti- John Cunningham virus (JCV) antibody test at Screening
  • History of allergy to MMF, BMS-986165, related compounds or any significant drug allergy

Other protocol defined inclusion/exclusion criteria could apply

Treatment and study plan

BMS-986165

Drug

Specified dose on specified days

MMF

Drug

Specified dose on specified days

Other names: Mycophenolate Mofetil

Primary outcomes

  1. Maximum plasma concentration (Cmax) of mycophenolic acid (MPA)

    Time frame: 18 days

  2. Area under the concentration vs time curve from time zero to the last quantifiable plasma concentration (AUC[0-T]) of MPA

    Time frame: 18 days

  3. AUC extrapolated to infinity (AUC[INF]) of MPA

    Time frame: 18 days

Secondary outcomes

  1. Number of adverse events (AE)

    Time frame: Up to 48 days

  2. Number of serious adverse events (SAE)

    Time frame: Up to 48 days

  3. Number of AEs leading to discontinuation

    Time frame: Up to 48 days

  4. Incidence of clinically significant changes in laboratory test results, vital sign measurements, electrocardiograms (ECGs) and physical examination results

    Time frame: 18 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

An Open-label, Single-sequence Study to Investigate the Effects of BMS-986165 at Steady State on the Single Dose Pharmacokinetics of Mycophenolate Mofetil (MMF) in Healthy Male Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 6, 2018
Registry last updated
Dec 19, 2018

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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