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

June 11, 2020 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • PRA Health Sciences - Salt Lake

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Arm
Drug: BMS-986256
specified dose on specified days
Drug: Mycophenolate Mofetil
specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Mycophenolic Acid (MPA) PK parameter: Maximum observed plasma concentration (Cmax)
Time Frame: days 1-5 and days 26 -30
days 1-5 and days 26 -30
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
Days 1-5 and Days 26 -30
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
Days 1-5 and days 26 -30

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence of Adverse Events (AEs)
Time Frame: up to 51 days
up to 51 days
Incidence of Serious Adverse Events (SAEs)
Time Frame: up to 51 days
up to 51 days
Number of Clinically significant changes in lab assessment of blood serum
Time Frame: up to 51 days
up to 51 days
Number of Clinically significant changes in assessment of blood
Time Frame: up to 51 days
up to 51 days
Number of Clinically significant changes in lab assessment of urine
Time Frame: up to 51 days
up to 51 days
Vital signs of blood pressure
Time Frame: up to 51 days
up to 51 days
Vital signs of body temperature
Time Frame: up to 51 days
up to 51 days
Vital signs of respiratory rate
Time Frame: up to 51 days
up to 51 days
Number of Participants with abnormal physical examination findings
Time Frame: up to 51 days
up to 51 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 22, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 18, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 16, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IM026-022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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