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Completed

NCT Number: NCT04249284

Pharmacokinetics (Drug Levels in Blood) of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants

The purpose of this study is to characterize the pharmacokinetics (the way the body absorbs, distributes and eliminates the drug) of BMS 986165 given in the form of various prototypes of solid tablets to healthy participants.

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Key information

Conditions

Healthy Participants

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences Miami

Miami, Florida, 33126, 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

  • In the opinion of the investigator, a healthy participant is determined by having no clinically significant deviation from normal in medical history, physical examination,electrocardiograms, vital signs, and clinical laboratory determinations.
  • Body weight >= 50 kg at screening
  • Women and men must agree to follow specific methods of contraception, if applicable

Exclusion criteria

  • Any major surgery, per investigator's discretion, within 4 weeks of study drug administration
  • Inability to tolerate oral medication
  • History of allergy to BMS-986165 or related compounds

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

BMS-986165

Drug

Specified dose on specified days

BMS-986165 prototype 1

Drug

Specified dose on specified days

BMS-986165 prototype 2

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum concentration (Cmax) for BMS-986165 in plasma

    Time frame: Up to 18 days

  2. Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T)) for BMS-986165 in plasma

    Time frame: Up to 18 days

  3. Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) for BMS-986165 in plasma

    Time frame: Up to 18 days

Secondary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to 23 days

  2. Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to 55 days

  3. Number of clinically significant abnormalities in electrocardiogram (ECG) parameters

    Time frame: Up to 50 days

  4. Number of participants with vital sign abnormalities in body temperature

    Time frame: Up to 50 days

  5. Number of participants with vital sign abnormalities in respiratory rate

    Time frame: Up to 50 days

  6. Number of participants with vital sign abnormalities in heart rate

    Time frame: Up to 50 days

  7. Number of participants with vital sign abnormalities in blood pressure

    Time frame: Up to 50 days

  8. Number of participants with clinical laboratory test abnormalities: Hematology tests

    Time frame: Up to 50 days

  9. Number of participants with clinical laboratory test abnormalities: Clinical chemistry tests

    Time frame: Up to 50 days

  10. Number of participants with clinical laboratory test abnormalities: Urinalysis tests

    Time frame: Up to 50 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Study to Evaluate the Pharmacokinetics of BMS-986165 Administered as Various Prototypic Solid Tablet Formulations in Healthy Subjects

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 30, 2020
Registry last updated
Apr 9, 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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