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OpenTrials
Completed

NCT Number: NCT04039373

Effects of BMS-986256 at Steady State on the Single Dose Pharmacokinetics of Mycophenolate Mofetil

A Study to Investigate BMS-986256 at steady state and its effect on Mycophenolate Mofetil exposure in Healthy Male Participants

Completed

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Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences - Salt Lake

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.

Inclusion criteria

  • Healthy participant, defined as having no clinically significant active or ongoing medical condition, physical examination abnormality, abnormal ECG finding, with no current use of tobacco
  • A negative QuantiFERON-TB Gold® test result at screening or documentation of a negative result within 3 months of the screening visit and a weight ≥ 50 kg and BMI between 18.0 and 32.0 kg/m2 inclusive at screening.
  • Participants must not be current users (within 6 months before screening) of tobacco or tobacco- or nicotine-containing products; they must also be willing to refrain from using any of these products during their participation in the study.
  • Men who are sexually active with women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception (APPENDIX 4) for the duration of treatment with BMS-986256 or MMF, plus 5 half-lives of BMS-986256 (19 days) plus an additional 90 days (duration of sperm turnover) for a total of 109 days post treatment. In addition, participants must be willing to refrain from sperm donation during this time.

Exclusion criteria

  • Any significant acute or chronic medical illness or condition, in the opinion of the investigator in addition to prior exposure to BMS-986256
  • Major surgery within 4 weeks before study treatment administration, drug abuse or drug addiction.
  • Participants who have smoked or used smoking cessation or other nicotine-containing products within 6 months before the first dose of study drug.
  • History or presence of malignancy including hematological malignancies. However,participants with a history of basal cell or squamous cell carcinoma of the skin that has been completely and successfully treated with no evidence of recurrence may not be excluded, at the discretion of the investigator.

Treatment and study plan

BMS-986256

Drug

specified dose on specified days

Mycophenolate mofetil

Drug

specified dose on specified days

Primary outcomes

  1. Mycophenolic Acid (MPA) PK parameter: Maximum observed plasma concentration (Cmax)

    Time frame: days 1-5 and days 26 -30

  2. mycophenolic acid (MPA) PK parameter: area under the concentration-time curve from time zero to the time of the last quantifiable concentration AUC (0-T)

    Time frame: Days 1-5 and Days 26 -30

  3. Mycophenolic Acid (MPA) PK parameter:area under the concentration-time curve from time zero extrapolated to infinite time AUC (INF)

    Time frame: Days 1-5 and days 26 -30

Secondary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: up to 51 days

  2. Incidence of Serious Adverse Events (SAEs)

    Time frame: up to 51 days

  3. Number of Clinically significant changes in lab assessment of blood serum

    Time frame: up to 51 days

  4. Number of Clinically significant changes in assessment of blood

    Time frame: up to 51 days

  5. Number of Clinically significant changes in lab assessment of urine

    Time frame: up to 51 days

  6. Vital signs of blood pressure

    Time frame: up to 51 days

  7. Vital signs of body temperature

    Time frame: up to 51 days

  8. Vital signs of respiratory rate

    Time frame: up to 51 days

  9. Number of Participants with abnormal physical examination findings

    Time frame: up to 51 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-986256 at Steady State on the Single Dose Pharmacokinetics of Mycophenolate Mofetil in Healthy Male Participants

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 31, 2019
Registry last updated
Jun 16, 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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