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Completed

NCT Number: NCT03563950

An Investigational Study to Evaluate the Effect of Rifampin on the Singe Dose of Experimental Medication BMS-986224 in Healthy Participants

The purpose of this study is to investigate if the blood levels of experimental medication BMS-986224 will be changed when given together with Rifampin, an antibiotic that affects specific enzymes involved with the breakdown of BMS-986224.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

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 medical history, physical examination, ECGs, and clinical laboratory determinations
  • Body mass index (BMI)of 18.0to 30.0 kg/m2, inclusive, at screening

Exclusion criteria

  • Women of childbearing potential
  • Any significant acute or chronic medical illness
  • Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption or history of cholecystectomy

Other protocol defined inclusion/exclusion criteria may apply

Treatment and study plan

Rifampin

Drug

Specified dose on specified days

BMS-986224

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) of BMS-986224

    Time frame: 5 days

  2. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224

    Time frame: 5 days

  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224

    Time frame: 5 days

Secondary outcomes

  1. Biomarker plasma concentrations of BMS-986224

    Time frame: 5 days

  2. Time of maximum observed plasma concentration (Tmax) of BMS-986224

    Time frame: 5 days

  3. Terminal elimination half-life (T-HALF) of BMS-986224

    Time frame: 5 days

  4. Metabolite of BMS-986224 Cmax

    Time frame: 5 days

  5. Metabolite of BMS-986224 AUC(0-T)

    Time frame: 5 days

  6. Metabolite of BMS-986224 AUC(INF)

    Time frame: 5 days

  7. Incidence of nonserious adverse events (AE)

    Time frame: 17 days

  8. Incidence of serious adverse events (SAE)

    Time frame: 30 days

  9. Incidence of AEs leading to discontinuation

    Time frame: 17 days

  10. Composite results of vital signs, electrocardiograms, physical examinations,and clinical laboratory tests

    Time frame: 18 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase I, Open-Label Study to Evaluate the Effect of Rifampin on the Single Dose Pharmacokinetics, Safety and Tolerability of BMS-986224 in Healthy Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 20, 2018
Registry last updated
Aug 29, 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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