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A Study to Investigate BMS-986165 and Methotrexate in Healthy Male Patients

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT03402087
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
2.5
Actual Duration (Months)
12
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate effects of BMS-986165 on blood levels of methotrexate given as a single dose in healthy male patients.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
30 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 on the Single-Dose Pharmacokinetics of Methotrexate in Healthy Male Subjects
Actual Study Start Date :
Jan 8, 2018
Actual Primary Completion Date :
Mar 20, 2018
Actual Study Completion Date :
Mar 25, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: BMS-986165+Methotrexate+Leucovorin

Three treatments administered

Drug: Methotrexate
Specified dose on specified days
Other Names:
  • MTX

    • Drug: Leucovorin
    Specified dose on specified days
    Other Names:
  • LEU

    • Drug: BMS-986165
    Specified dose on specified days

    Outcome Measures

    Primary Outcome Measures

    1. Maximum observed plasma concentration (Cmax) [Approximately 14 days]

    2. Time to attain maximum observed plasma concentration (Tmax) [Approximately 14 days]

    3. Area under the plasma concentration-time curve up to time T, where T is the last point with concentrations above the lower limit of quantitation [AUC(0-T)] [Approximately 14 days]

    4. Area under the plasma concentration-time curve from time 0 to infinity [AUC(INF)] [Approximately 14 days]

    5. Terminal elimination rate constant (kel) [Approximately 14 days]

    6. Terminal elimination half life, calculated as 0.693/kel (T-HALF) [Approximately 14 days]

    7. Apparent oral clearance (CL/F) [Approximately 14 days]

    Secondary Outcome Measures

    1. Incidence of adverse events (AEs) [Approximately 19 days]

    2. Incidence of serious adverse events (SAEs) [Approximately 19 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:

    • Body Mass Index (BMI): 18.0 - 32.0 kg/m2

    • Normal renal function at screening

    Exclusion Criteria:

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

    • Any contraindication indicated in the MTX package insert

    • History or presence of chronic bacterial or viral infection

    • History or presence of an autoimmune disorder

    • Any significant acute or chronic medical illness

    • Active TB requiring treatment or documented latent TB within the previous 3 years

    • Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption

    Other protocol defined inclusion/exclusion criteria could apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 PRA Health Sciences Groningen Netherlands 9728 NZ

    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:
    NCT03402087
    Other Study ID Numbers:
    • IM011-025
    • 2017-004177-13
    First Posted:
    Jan 18, 2018
    Last Update Posted:
    Feb 25, 2020
    Last Verified:
    Feb 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Arthritis, Psoriatic
    Leucovorin
    Methotrexate
    BMS-986165

    Study Results

    No Results Posted as of Feb 25, 2020