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Completed

NCT Number: NCT03346837

A Study to Evaluate the Effect of 2 Drugs on the Pharmacokinetics of BMS-986205 in Healthy Subjects

Assess the effects of itraconazole and rifampin on the pharmacokinetics, safety, and tolerability of BMS-986205.

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Key information

Conditions

Malignancies Multiple

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD

Austin, Texas, 78744, United States

About this study

A randomized, open-label, parallel design study in healthy participants to assess the effects of itraconazole and rifampin on the single-dose pharmacokinetics of BMS-986205. Safety and tolerability data to be collected and assessed as well.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body mass index 18.0 to 32.0 kg/m2, inclusive
  • Must have normal renal function demonstrated by GFR, calculated by Chronic Kidney Disease Epidemiology Collaboration formula
  • Women must not be of childbearing potential (cannot become pregnant)

Exclusion criteria

  • Any significant acute or chronic medical illness
  • History of glucose-6-phosphodiesterase (G6PD) deficiency
  • Personal or family history of cytochrome b5 reductase deficiency

Other protocol defined inclusion / exclusion criteria could apply

Treatment and study plan

BMS-986205

Drug

BMS-986205

Itraconazole

Drug

Oral solution

Rifampin

Drug

Tablet

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 25 days

    Measured by plasma concentration

  2. AUC from time zero to time of last quantifiable concentration (AUC(0-T))

    Time frame: Up to 25 days

    Measured by plasma concentration

  3. AUC from time zero extrapolated to infinite time (AUC(INF))

    Time frame: Up to 25 days

    Measured by plasma concentration

Secondary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to 25 days

    Safety and tolerability as measured by incidence of AEs

  2. Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to 76 days

    Safety and tolerability as measured by incidence of SAEs

  3. Number of participants with electrocardiogram abnormalities

    Time frame: Up to 25 days

  4. Number of participants with physical examination findings abnormalities

    Time frame: Up to 25 days

  5. Number of participants with clinical laboratory abnormalities

    Time frame: Up to 25 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Randomized, Open-Label, Four-Cohort, Parallel Design Study to Evaluate the Effect of Itraconazole or Rifampin on the Single-Dose Pharmacokinetics of BMS-986205 in Normal Healthy Participants

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 17, 2017
Registry last updated
Feb 28, 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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