Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 10, 2019
First Posted Date  ICMJE September 12, 2019
Last Update Posted Date November 28, 2019
Actual Study Start Date  ICMJE September 10, 2019
Actual Primary Completion Date October 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2019)
  • Maximum observed serum comcentration (Cmax) [ Time Frame: Day 1, Day 5 ]
  • Area under the concentration-time curve from time zero extrapolated to AUC(INF) [ Time Frame: Day 1, Day 5 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04086719 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2019)
  • Incidences of Adverse Events (AE's) [ Time Frame: Approximetly 20 days ]
  • Time of maximum observed concentration (Tmax) [ Time Frame: Approxmiately 20 days ]
  • Half- life time (T-Half) [ Time Frame: Day 1, Day 5 ]
  • Apparent oral clearance (CL/F) [ Time Frame: Day 5 ]
  • Apparent volume of distribution at terminal phase (Vz/F) [ Time Frame: Day 5 ]
  • Ratio of metabolite AUC(0-T) to parent AUC(0-T) corrected for Molecular weight MRAUC(0-T) [ Time Frame: Day 5 ]
  • Ratio of metabolite AUC(INF) to parent AUC(INF) corrected for Moecular weight MRAUC(INF) [ Time Frame: Day 5 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Investigational Study to Determine the Drug Level Profile of BMS-986165 in Healthy Male Volunteers Following Transporter Inhibition.
Official Title  ICMJE 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.
Brief Summary Study of what the body does to drug BMS-986165 when it is taken together with pyrimethamine
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Male Volunteers
Intervention  ICMJE
  • Drug: BMS-986165
    Oral administration of tablet BMS- 986165
  • Drug: Pyrimethamine
    Oral administration of Pyrimethamine in combination with BMS-986185
Study Arms  ICMJE
  • Experimental: BMS- 986185 + Pyrimethamine
    Intervention: Drug: Pyrimethamine
  • Experimental: BMS-986185
    Intervention: Drug: BMS-986165
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 25, 2019)
16
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2019)
18
Actual Study Completion Date  ICMJE October 29, 2019
Actual Primary Completion Date October 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04086719
Other Study ID Numbers  ICMJE IM011-100
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bristol-Myers Squibb
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP