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OpenTrials
Completed

NCT Number: NCT03402087

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

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.

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Key information

Conditions

Lupus Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Psoriatic Arthritis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences

Groningen, 9728 NZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methotrexate

Drug

Specified dose on specified days

Other names: MTX

Leucovorin

Drug

Specified dose on specified days

Other names: LEU

BMS-986165

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Approximately 14 days

  2. Time to attain maximum observed plasma concentration (Tmax)

    Time frame: 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)]

    Time frame: Approximately 14 days

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

    Time frame: Approximately 14 days

  5. Terminal elimination rate constant (kel)

    Time frame: Approximately 14 days

  6. Terminal elimination half life, calculated as 0.693/kel (T-HALF)

    Time frame: Approximately 14 days

  7. Apparent oral clearance (CL/F)

    Time frame: Approximately 14 days

Secondary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Approximately 19 days

  2. Incidence of serious adverse events (SAEs)

    Time frame: Approximately 19 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 18, 2018
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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