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

Healthy Male Volunteers Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04086719
• Other study ID #: IM011-100
• Status: Completed
• Phase: Phase 1
• Start date: September 12, 2019
• Est. completion date: October 29, 2019

Study information

• Verified date: August 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 29, 2019
• Est. primary completion date: October 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Male Volunteers

Intervention

Drug:
• BMS-986165
Oral administration of tablet BMS- 986165
• Pyrimethamine
Oral administration of Pyrimethamine in combination with BMS-986185

Locations

Country	Name	City	State
United States	PRA Health Sciences - Salt Lake	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed serum comcentration (Cmax)		Day 1, Day 5
Primary	Area under the concentration-time curve from time zero extrapolated to AUC(INF)		Day 1, Day 5
Secondary	Incidences of Adverse Events (AE's)		Approximetly 20 days
Secondary	Time of maximum observed concentration (Tmax)		Approxmiately 20 days
Secondary	Half- life time (T-Half)		Day 1, Day 5
Secondary	Apparent oral clearance (CL/F)		Day 5
Secondary	Apparent volume of distribution at terminal phase (Vz/F)		Day 5
Secondary	Ratio of metabolite AUC(0-T) to parent AUC(0-T) corrected for Molecular weight MRAUC(0-T)		Day 5
Secondary	Ratio of metabolite AUC(INF) to parent AUC(INF) corrected for Moecular weight MRAUC(INF)		Day 5

External Links

•   BMS Clinical Trial Information
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•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form