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Completed

NCT Number: NCT04086719

An Investigational Study to Determine the Drug Level Profile of BMS-986165 in Healthy Male Volunteers Following Transporter Inhibition.

Study of what the body does to drug BMS-986165 when it is taken together with pyrimethamine

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Key information

Conditions

Healthy Male Volunteers

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences - Salt Lake

Salt Lake City, Utah, 84124, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients must be willing and able to complete all study-specific procedures and visits
  • Healthy patients, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram, and clinical laboratory determinations
  • Body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening
  • Normal renal function at screening

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
  • Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
  • History or presence of clinically significant acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening
  • Additional criteria may apply

Treatment and study plan

BMS-986165

Drug

Oral administration of tablet BMS- 986165

Pyrimethamine

Drug

Oral administration of Pyrimethamine in combination with BMS-986185

Primary outcomes

  1. Maximum observed serum comcentration (Cmax)

    Time frame: Day 1, Day 5

  2. Area under the concentration-time curve from time zero extrapolated to AUC(INF)

    Time frame: Day 1, Day 5

Secondary outcomes

  1. Incidences of Adverse Events (AE's)

    Time frame: Approximetly 20 days

  2. Time of maximum observed concentration (Tmax)

    Time frame: Approxmiately 20 days

  3. Half- life time (T-Half)

    Time frame: Day 1, Day 5

  4. Apparent oral clearance (CL/F)

    Time frame: Day 5

  5. Apparent volume of distribution at terminal phase (Vz/F)

    Time frame: Day 5

  6. Ratio of metabolite AUC(0-T) to parent AUC(0-T) corrected for Molecular weight MRAUC(0-T)

    Time frame: Day 5

  7. Ratio of metabolite AUC(INF) to parent AUC(INF) corrected for Moecular weight MRAUC(INF)

    Time frame: Day 5

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

An Open-Label, Single Sequence, Crossover Study to Investigate the Effects of OCT1 Inhibition Utilizing Pyrimethamine on Pharmacokinetics of BMS-986165 in Healthy Male Volunteers.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 12, 2019
Registry last updated
Aug 5, 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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