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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT04086719
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
1.5
Actual Duration (Months)
10.4
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Sep 12, 2019
Actual Primary Completion Date :
Oct 29, 2019
Actual Study Completion Date :
Oct 29, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Maximum observed serum comcentration (Cmax) [Day 1, Day 5]

  2. Area under the concentration-time curve from time zero extrapolated to AUC(INF) [Day 1, Day 5]

Secondary Outcome Measures

  1. Incidences of Adverse Events (AE's) [Approximetly 20 days]

  2. Time of maximum observed concentration (Tmax) [Approxmiately 20 days]

  3. Half- life time (T-Half) [Day 1, Day 5]

  4. Apparent oral clearance (CL/F) [Day 5]

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

  6. Ratio of metabolite AUC(0-T) to parent AUC(0-T) corrected for Molecular weight MRAUC(0-T) [Day 5]

  7. Ratio of metabolite AUC(INF) to parent AUC(INF) corrected for Moecular weight MRAUC(INF) [Day 5]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
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:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 PRA Health Sciences - Salt Lake Salt Lake City Utah United States 84124

Sponsors and Collaborators

  • Bristol-Myers Squibb

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT04086719
Other Study ID Numbers:
  • IM011-100
First Posted:
Sep 12, 2019
Last Update Posted:
Aug 5, 2020
Last Verified:
Aug 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pyrimethamine
BMS-986165

Study Results

No Results Posted as of Aug 5, 2020