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Completed

NCT Number: NCT03419910

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

This is an investigational study of Cyclosporine on the experimental medication BMS-986165 in healthy male participants.

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Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences

Salt Lake City, Utah, 84124, 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 medical history, physical examination, ECGs, and clinical laboratory determinations
  • Body mass index 18.0 to 32.0 kg/m2
  • Weight ≥ 50 kg

Exclusion criteria

  • Any medical condition that presents a potential risk to the subject and/or may compromise the objectives of the study, including a history of or active liver disease
  • History or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening
  • Known or suspected autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
  • History of administration of live vaccines within 60 days before screening
  • Any history or risk for tuberculosis (TB)

Other protocol defined inclusion/exclusion criteria could apply

Treatment and study plan

BMS-986165

Drug

Specified dose on specified days

cyclosporine

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum concentration (Cmax)

    Time frame: 24 hours

  2. Area under the concentration vs time curve from time zero to 24 hours post dose (AUC[0-24])

    Time frame: 24 hours

Secondary outcomes

  1. Adverse events (AEs)

    Time frame: Up to 20 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 Cyclosporine on the Pharmacokinetics of BMS-986165 at Steady State in Healthy Male Participants

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 5, 2018
Registry last updated
Mar 18, 2020

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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