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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04039373
Recruitment Status : Completed
First Posted : July 31, 2019
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: BMS-986256 Drug: Mycophenolate Mofetil Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : July 22, 2019
Actual Primary Completion Date : September 18, 2019
Actual Study Completion Date : October 16, 2019


Arm Intervention/treatment
Experimental: Treatment Arm Drug: BMS-986256
specified dose on specified days

Drug: Mycophenolate Mofetil
specified dose on specified days




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039373


Locations
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United States, Utah
PRA Health Sciences - Salt Lake
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04039373    
Other Study ID Numbers: IM026-022
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action