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

February 24, 2020 updated by: Bristol-Myers Squibb

An Open-Label, Single-Sequence Study to Investigate the Effects of BMS-986165 on the Single-Dose Pharmacokinetics of Methotrexate in Healthy Male Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • 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

  • Netherlands
      • Groningen, Netherlands, 9728 NZ
        • PRA Health Sciences

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

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

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: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: BMS-986165+Methotrexate+Leucovorin
Three treatments administered
Drug: BMS-986165
Specified dose on specified days
Drug: Leucovorin
Specified dose on specified days
Other Names:
  • LEU
Drug: Methotrexate
Specified dose on specified days
Other Names:
  • MTX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed plasma concentration (Cmax)
Time Frame: Approximately 14 days
Approximately 14 days
Time to attain maximum observed plasma concentration (Tmax)
Time Frame: Approximately 14 days
Approximately 14 days
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)]
Time Frame: Approximately 14 days
Approximately 14 days
Area under the plasma concentration-time curve from time 0 to infinity [AUC(INF)]
Time Frame: Approximately 14 days
Approximately 14 days
Terminal elimination rate constant (kel)
Time Frame: Approximately 14 days
Approximately 14 days
Terminal elimination half life, calculated as 0.693/kel (T-HALF)
Time Frame: Approximately 14 days
Approximately 14 days
Apparent oral clearance (CL/F)
Time Frame: Approximately 14 days
Approximately 14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events (AEs)
Time Frame: Approximately 19 days
Approximately 19 days
Incidence of serious adverse events (SAEs)
Time Frame: Approximately 19 days
Approximately 19 days

Collaborators and Investigators

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

Sponsor

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)

January 8, 2018

Primary Completion (ACTUAL)

March 20, 2018

Study Completion (ACTUAL)

March 25, 2018

Study Registration Dates

First Submitted

January 5, 2018

First Submitted That Met QC Criteria

January 16, 2018

First Posted (ACTUAL)

January 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 24, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM011-025
  • 2017-004177-13 (EUDRACT_NUMBER)

Drug and device information, study documents

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

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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