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CompletedNCT04086719Updated Aug 5, 2020

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

A Phase 1 interventional study of BMS-986165 and Pyrimethamine in Healthy Male Volunteers, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-05.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Oct 2019, 6 years 11 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Healthy Male Volunteers
03

In context

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    BMS- 986185 + Pyrimethamine

    Drug: Pyrimethamine

  • Experimental
    BMS-986185

    Drug: BMS-986165

Interventions

  • DrugBMS-986165

    Oral administration of tablet BMS- 986165

  • DrugPyrimethamine

    Oral administration of Pyrimethamine in combination with BMS-986185

06

What researchers measure

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

07

Study locations

1 site
  • PRA Health Sciences - Salt Lake
    Salt Lake City, Utah 84124, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04086719
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Sep 12, 2019
Start date
Sep 12, 2019
Primary completion
Oct 29, 2019
Completion
Oct 29, 2019
Last update
Aug 5, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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