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An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT03660436
Collaborator
(none)
131
Enrollment
1
Location
1
Arm
2.1
Actual Duration (Months)
61.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the effects of experimental medication BMS-986165 in healthy male participants.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
131 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Single-sequence Study to Investigate the Effects of BMS-986165 at Steady State on the Single Dose Pharmacokinetics of Mycophenolate Mofetil (MMF) in Healthy Male Subjects
Actual Study Start Date :
Aug 14, 2018
Actual Primary Completion Date :
Oct 10, 2018
Actual Study Completion Date :
Oct 18, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: BMS-986165 + MMF

Oral administration

Drug: BMS-986165
Specified dose on specified days

Drug: MMF
Specified dose on specified days
Other Names:
  • Mycophenolate Mofetil

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum plasma concentration (Cmax) of mycophenolic acid (MPA) [18 days]

    2. Area under the concentration vs time curve from time zero to the last quantifiable plasma concentration (AUC[0-T]) of MPA [18 days]

    3. AUC extrapolated to infinity (AUC[INF]) of MPA [18 days]

    Secondary Outcome Measures

    1. Number of adverse events (AE) [Up to 48 days]

    2. Number of serious adverse events (SAE) [Up to 48 days]

    3. Number of AEs leading to discontinuation [Up to 48 days]

    4. Incidence of clinically significant changes in laboratory test results, vital sign measurements, electrocardiograms (ECGs) and physical examination results [18 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes

    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 physical examination, electrocardiograms (ECGs), and clinical laboratory determinations

    • Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening

    • Normal renal function at screening as evidenced by an estimated GFR (glomerular filtration rate) > 80 mL/min/1.732 m2

    Exclusion Criteria:

    • Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease

    • Positive anti- John Cunningham virus (JCV) antibody test at Screening

    • History of allergy to MMF, BMS-986165, related compounds or any significant drug allergy

    Other protocol defined inclusion/exclusion criteria could apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 PRA Health Sciences Salt Lake City Utah United States 84107

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT03660436
    Other Study ID Numbers:
    • IM011-071
    First Posted:
    Sep 6, 2018
    Last Update Posted:
    Dec 19, 2018
    Last Verified:
    Dec 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Mycophenolic Acid
    BMS-986165

    Study Results

    No Results Posted as of Dec 19, 2018