Clinical trial NCT04008992: An Ascending Dose Study of BMS-986259 to Study Safety in Healthy Participants
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BMS-986259 in Healthy Participants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-07-05
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 7 weeks
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: up to 7 weeks
measure: AEs leading to discontinuation
timeFrame: Up to 7 weeks
measure: Number of clinically significant changes in vital signs
timeFrame: Up to 7 weeks
measure: Number of clinically significant changes in ECG (electrocardiogram)
timeFrame: Up to 7 weeks
measure: Number of clinically significant changes in physical examinations
timeFrame: Up to 7 weeks
measure: Number of clinically significant changes in clinical laboratory tests
timeFrame: Up to 7 weeks
Secondary outcomes:
measure: Maximum observed concentration(Cmax)- Part A SAD
timeFrame: up to 7 weeks
measure: Time of maximum observed concentration(Tmax)- Part A SAD
timeFrame: Up to 7 weeks
measure: Terminal elimination rate constant (Lz)-Part A SAD
timeFrame: up to 7 weeks
measure: Half life (T-HALF)- Part A SAD
timeFrame: Up to 7 weeks
measure: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration(AUC(0-T)- Part A SAD
timeFrame: Up to 7 weeks
measure: Area under the concentration-time curve from time zero extrapolated to infinite time(AUC(INF)-Part A SAD
timeFrame: Up to 7 weeks
measure: Apparent total body clearance(CL/F)-Part A SAD
timeFrame: Up to 7 weeks
measure: Apparent volume of distribution at terminal phase(Vz/F)- Part A SAD
timeFrame: Up to 7 weeks
measure: Maximum observed concentration(Cmax)-Part B and Part C MAD
timeFrame: Up to 7 years
measure: Time of maximum observed concentration(Tmax)-Part B and Part C MAD
timeFrame: Up tp 7 weeks
measure: Area under the concentration-time curve in one dosing interval(AUC(TAU)- Part B and Part C MAD
timeFrame: Up to 7 weeks
measure: 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
timeFrame: Up to 7 weeks
measure: Terminal elimination rate constant (Lz)-Part B and Part C MAD
timeFrame: up to 7 weeks
measure: Half life (T-HALF)- Part B and Part C MAD
timeFrame: Up to 7 weeks
measure: Apparent total body clearance(CL/F)-Part B and Part C MAD
timeFrame: Up to 7 weeks
measure: Apparent volume of distribution at terminal phase(Vz/F)- Part B and Part C MAD
timeFrame: Up to 7 weeks
measure: Accumulation Ratio Cmax (AR(Cmax)-Part B and Part C MAD
timeFrame: Up to 7 weeks
measure: Accumulation Ratio AUC(TAU) (AR(AUC[TAU])- Part B and Part C MAD
timeFrame: Up to 7 weeks
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences - Groningen
city: London
country: United Kingdom
facility: Richmond Pharmacology
Study officials:
References: