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

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ClinicalTrials.gov Identifier: NCT04086719
Recruitment Status : Completed
First Posted : September 12, 2019
Last Update Posted : November 28, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Healthy Male Volunteers Drug: BMS-986165 Drug: Pyrimethamine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : September 10, 2019
Actual Primary Completion Date : October 29, 2019
Actual Study Completion Date : October 29, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BMS- 986185 + Pyrimethamine Drug: Pyrimethamine
Oral administration of Pyrimethamine in combination with BMS-986185

Experimental: BMS-986185 Drug: BMS-986165
Oral administration of tablet BMS- 986165




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04086719


Locations
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United States, Utah
PRA Health Sciences - Salt Lake
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04086719     History of Changes
Other Study ID Numbers: IM011-100
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: November 28, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pyrimethamine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action