An Investigational Study to Determine the Drug Level Profile of BMS-986165 in Healthy Male Volunteers Following Transporter Inhibition.
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.
1 other identifier
interventional
16
1 country
1
Brief Summary
Study of what the body does to drug BMS-986165 when it is taken together with pyrimethamine
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2019
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2019
CompletedFirst Posted
Study publicly available on registry
September 12, 2019
CompletedStudy Start
First participant enrolled
September 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 29, 2019
CompletedAugust 5, 2020
August 1, 2020
2 months
September 10, 2019
August 3, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Maximum observed serum comcentration (Cmax)
Day 1, Day 5
Area under the concentration-time curve from time zero extrapolated to AUC(INF)
Day 1, Day 5
Secondary Outcomes (7)
Incidences of Adverse Events (AE's)
Approximetly 20 days
Time of maximum observed concentration (Tmax)
Approxmiately 20 days
Half- life time (T-Half)
Day 1, Day 5
Apparent oral clearance (CL/F)
Day 5
Apparent volume of distribution at terminal phase (Vz/F)
Day 5
- +2 more secondary outcomes
Study Arms (2)
BMS- 986185 + Pyrimethamine
EXPERIMENTALBMS-986185
EXPERIMENTALInterventions
Oral administration of Pyrimethamine in combination with BMS-986185
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PRA Health Sciences - Salt Lake
Salt Lake City, Utah, 84124, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2019
First Posted
September 12, 2019
Study Start
September 12, 2019
Primary Completion
October 29, 2019
Study Completion
October 29, 2019
Last Updated
August 5, 2020
Record last verified: 2020-08