Status:

COMPLETED

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

Lead Sponsor:

Bristol-Myers Squibb

Conditions:

Healthy Male Volunteers

Eligibility:

MALE

18-50 years

Phase:

PHASE1

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 12 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 29 2019

Estimated Enrollment :

16 Patients enrolled

Trial Details

Trial ID

NCT04086719

Start Date

September 12 2019

End Date

October 29 2019

Last Update

August 5 2020

Active Locations (1)

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Page 1 of 1 (1 locations)

1

PRA Health Sciences - Salt Lake

Salt Lake City, Utah, United States, 84124