An Ascending Dose Study of BMS-986259 to Study Safety in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy Participants
- Interventions
- Drug: BMS-986259Other: PlaceboDiagnostic Test: P-AminohippurateDiagnostic Test: Iohexol
- Registration Number
- NCT04008992
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
A Randomized double blind, placebo controlled study of BMS-986259 to evaluate the safety and effectiveness of the drug amongst different conditions and populations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
Inclusion Criteria
- Healthy participants with a body mass Index (BMI) of 18.0 kg/m^2 - 30.0 kg/m^2.
- Males and females not of child bearing potential.
- Participants in the Japanese Cohorts in Part C must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese.)
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Exclusion Criteria
- Any previous dosing in another cohort in the current study or participation in an investigational drug within 2 months prior to (the first) drug administration in the current study.
- Any Significant Acute or Chronic medical Illness, major surgery in 12 months, or so smoking or used smoking cessation in 3 months.
- Inability to be venipunctured and/or tolerate venous access. ,abnormalities in hemoglobin or positive screen for hepatitis C, Hepatitis B, Human Immunodeficiency Virus (HIV), including hepatic disease
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part C JMAD - C2 Cohort P-Aminohippurate Japanese Multiple Ascending Dose Part C JMAD - C3 Cohort Placebo Japanese Multiple Ascending Dose Part A SAD- A6 Cohort BMS-986259 Single Ascending dose Part A SAD- A6 Cohort Placebo Single Ascending dose Part B MAD - B3 Cohort Iohexol Multiple Ascending Dose Part A SAD- A6 Cohort Iohexol Single Ascending dose Part C JMAD - C1 Cohort P-Aminohippurate Japanese Multiple Ascending Dose Part A SAD - A5 Cohort Iohexol Single Ascending dose Part A SAD - A2 Cohort Iohexol Single Ascending dose Part B MAD- B1 Cohort Placebo Multiple Ascending Dose Part A SAD - A2 Cohort BMS-986259 Single Ascending dose Part A SAD- A3 Cohort BMS-986259 Single Ascending dose Part A SAD- A3 Cohort Iohexol Single Ascending dose Part A SAD- A4 Cohort BMS-986259 Single Ascending dose Part A SAD- A4 Cohort Placebo Single Ascending dose Part A SAD- A4 Cohort P-Aminohippurate Single Ascending dose Part A SAD - A1 Cohort P-Aminohippurate Single Ascending Dose Part A SAD - A5 Cohort BMS-986259 Single Ascending dose Part A SAD - A5 Cohort P-Aminohippurate Single Ascending dose Part A SAD - A1 Cohort Iohexol Single Ascending Dose Part A SAD - A2 Cohort P-Aminohippurate Single Ascending dose Part A SAD- A3 Cohort Placebo Single Ascending dose Part A SAD- A6 Cohort P-Aminohippurate Single Ascending dose Part A SAD - A1 Cohort BMS-986259 Single Ascending Dose Part A SAD - A1 Cohort Placebo Single Ascending Dose Part A SAD - A2 Cohort Placebo Single Ascending dose Part A SAD- A3 Cohort P-Aminohippurate Single Ascending dose Part A SAD- A4 Cohort Iohexol Single Ascending dose Part A SAD - A5 Cohort Placebo Single Ascending dose Part B MAD- B1 Cohort Iohexol Multiple Ascending Dose Part B MAD - B2 Cohort BMS-986259 Multiple Ascending Dose Part B MAD - B2 Cohort Placebo Multiple Ascending Dose Part B MAD - B2 Cohort Iohexol Multiple Ascending Dose Part C JMAD - C1 Cohort BMS-986259 Japanese Multiple Ascending Dose Part B MAD- B1 Cohort BMS-986259 Multiple Ascending Dose Part B MAD - B3 Cohort Placebo Multiple Ascending Dose Part B MAD - B4 Cohort BMS-986259 Multiple Ascending Dose Part B MAD - B4 Cohort P-Aminohippurate Multiple Ascending Dose Part C JMAD - C2 Cohort Placebo Japanese Multiple Ascending Dose Part B MAD- B1 Cohort P-Aminohippurate Multiple Ascending Dose Part B MAD - B2 Cohort P-Aminohippurate Multiple Ascending Dose Part B MAD - B3 Cohort BMS-986259 Multiple Ascending Dose Part B MAD - B3 Cohort P-Aminohippurate Multiple Ascending Dose Part B MAD - B4 Cohort Iohexol Multiple Ascending Dose Part B MAD - B4 Cohort Placebo Multiple Ascending Dose Part C JMAD - C1 Cohort Placebo Japanese Multiple Ascending Dose Part C JMAD - C2 Cohort BMS-986259 Japanese Multiple Ascending Dose Part C JMAD - C2 Cohort Iohexol Japanese Multiple Ascending Dose Part C JMAD - C3 Cohort BMS-986259 Japanese Multiple Ascending Dose Part C JMAD - C3 Cohort P-Aminohippurate Japanese Multiple Ascending Dose Part C JMAD - C1 Cohort Iohexol Japanese Multiple Ascending Dose Part C JMAD - C3 Cohort Iohexol Japanese Multiple Ascending Dose
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events (AEs) Up to 7 weeks Number of clinically significant changes in vital signs Up to 7 weeks Number of clinically significant changes in physical examinations Up to 7 weeks AEs leading to discontinuation Up to 7 weeks Incidence of Serious Adverse Events (SAEs) up to 7 weeks Number of clinically significant changes in ECG (electrocardiogram) Up to 7 weeks Number of clinically significant changes in clinical laboratory tests Up to 7 weeks
- Secondary Outcome Measures
Name Time Method Terminal elimination rate constant (Lz)-Part B and Part C MAD up to 7 weeks For day 14
Accumulation Ratio Cmax (AR(Cmax)-Part B and Part C MAD Up to 7 weeks For day 14
Maximum observed concentration(Cmax)-Part B and Part C MAD Up to 7 years For day 1 , day 13 and day 14
Half life (T-HALF)- Part B and Part C MAD Up to 7 weeks For day 14
Area under the concentration-time curve in one dosing interval(AUC(TAU)- Part B and Part C MAD Up to 7 weeks For day 1 and day 14
Half life (T-HALF)- Part A SAD Up to 7 weeks Apparent total body clearance(CL/F)-Part A SAD Up to 7 weeks Area under the concentration-time curve from time zero to the time of the last quantifiable concentration(AUC(0-T)-Part B and Part C MAD Up to 7 weeks For Day 14
Apparent volume of distribution at terminal phase(Vz/F)- Part B and Part C MAD Up to 7 weeks For day 14
Terminal elimination rate constant (Lz)-Part A SAD up to 7 weeks Area under the concentration-time curve from time zero to the time of the last quantifiable concentration(AUC(0-T)- Part A SAD Up to 7 weeks Maximum observed concentration(Cmax)- Part A SAD up to 7 weeks Time of maximum observed concentration(Tmax)- Part A SAD Up to 7 weeks Area under the concentration-time curve from time zero extrapolated to infinite time(AUC(INF)-Part A SAD Up to 7 weeks Apparent volume of distribution at terminal phase(Vz/F)- Part A SAD Up to 7 weeks Time of maximum observed concentration(Tmax)-Part B and Part C MAD Up tp 7 weeks For day 1, day 13 and day 14
Apparent total body clearance(CL/F)-Part B and Part C MAD Up to 7 weeks For day 14
Accumulation Ratio AUC(TAU) (AR(AUC[TAU])- Part B and Part C MAD Up to 7 weeks for day 14
Trial Locations
- Locations (2)
PRA Health Sciences - Groningen
🇳🇱Groningen, Netherlands
Richmond Pharmacology
🇬🇧London, United Kingdom