Healthy Participants
Conditions
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.
Interventions
DRUGBMS-986259
Single and Multiple ascending dose from Dose 1 to Dose 5
OTHERPlacebo
Placebo matching BMS-986259
DIAGNOSTIC_TESTP-Aminohippurate
Diagnostic Agent
DIAGNOSTIC_TESTIohexol
Diagnostic Agent
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.)
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events (AEs) | Up to 7 weeks |
| Incidence of Serious Adverse Events (SAEs) | up to 7 weeks |
| AEs leading to discontinuation | Up to 7 weeks |
| Number of clinically significant changes in vital signs | Up to 7 weeks |
| Number of clinically significant changes in ECG (electrocardiogram) | Up to 7 weeks |
| Number of clinically significant changes in physical examinations | Up to 7 weeks |
| Number of clinically significant changes in clinical laboratory tests | Up to 7 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apparent volume of distribution at terminal phase(Vz/F)- Part A SAD | Up to 7 weeks | — |
| Maximum observed concentration(Cmax)-Part B and Part C MAD | Up to 7 years | For day 1 , day 13 and day 14 |
| Time of maximum observed concentration(Tmax)-Part B and Part C MAD | Up tp 7 weeks | For day 1, day 13 and 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 |
| 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 |
| Maximum observed concentration(Cmax)- Part A SAD | up to 7 weeks | — |
| Half life (T-HALF)- Part B and Part C MAD | Up to 7 weeks | For day 14 |
| Apparent total body clearance(CL/F)-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 |
| Accumulation Ratio Cmax (AR(Cmax)-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 |
| Terminal elimination rate constant (Lz)-Part B and Part C MAD | up to 7 weeks | For day 14 |
| Time of maximum observed concentration(Tmax)- Part A SAD | Up to 7 weeks | — |
| Terminal elimination rate constant (Lz)-Part A SAD | up to 7 weeks | — |
| Half life (T-HALF)- 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 | — |
| Area under the concentration-time curve from time zero extrapolated to infinite time(AUC(INF)-Part A SAD | Up to 7 weeks | — |
| Apparent total body clearance(CL/F)-Part A SAD | Up to 7 weeks | — |
Countries
Netherlands, United Kingdom
Outcome results
None listed