Clinical trial NCT02079480: Study to Evaluate the Safety, Tolerability, PK, and PD of BMS-986090 in Healthy Subjects
Official title: Double-Blinded, Randomized, Placebo-Controlled, Single Ascending Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986090 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Adult Volunteers
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-03-05
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BMS-986090 in healthy subjects.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Healthy male and female (of not childbearing potential), ages 18-45 years, inclusive
* BMI 18 to 32 kg/m2, inclusive

Exclusion Criteria:

- Any significant acute or chronic medical illness

Primary outcomes:
measure: Safety and tolerability of single dose measured by incidence, potential significance and clinical importance of AEs, as determined by medical review of AE reports, vital sign measurements, ECGs and results of physical examination and laboratory tests
timeFrame: Up to Day 85 after single dose of BMS-986090
measure: Safety and tolerability of multiple dose measured by incidence, potential significance and clinical importance of AEs, as determined by medical review of AE reports, vital sign measurements, ECGs and results of physical examination and laboratory tests
timeFrame: Up to Day 106 after multiple dose of BMS-986090
Secondary outcomes:
measure: Maximum observed serum concentration (Cmax) of BMS-986090 single dose subcutaneous (SC) and intravenous (IV)
timeFrame: Days 1 -85
measure: Time of maximum observed serum concentration (Tmax) of single dose BMS-986090 SC and IV
timeFrame: Days 1 -85
measure: Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of single dose BMS-986090 SC and IV
timeFrame: Days 1 -85
measure: Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of single dose BMS-986090 SC and IV
timeFrame: Days 1 -85
measure: Terminal serum half-life (T-HALF) of single dose BMS-986090 SC and IV
timeFrame: Days 1 -85
measure: Total body clearance (CLT) of single dose BMS-986090 IV
timeFrame: Days 1 -85
measure: Apparent total body clearance (CLT/F) of single dose BMS-986090 SC
timeFrame: Days 1 -85
measure: Volume of distribution at terminal phase (Vz) of single dose BMS-986090 IV
timeFrame: Days 1 -85
measure: Volume of distribution during steady state (Vss) of single dose BMS-986090 IV
timeFrame: Days 1 -85
measure: Apparent volume of distribution at terminal phase (Vz/F) of single dose BMS-986090 SC
timeFrame: Days 1 -85
measure: Absolute bioavailability (F) of single dose BMS-986090 SC
timeFrame: Days 1 -85
measure: Maximum observed serum concentration (Cmax) of multiple dose BMS-986090 SC
timeFrame: Days 1 -106
measure: Time of maximum observed serum concentration (Tmax) of multiple dose BMS-986090 SC
timeFrame: Days 1 -106
measure: Terminal serum half-life (T-HALF) of multiple dose BMS-986090 SC
timeFrame: Days 1 -106
measure: Area under the serum concentration-time curve in one dosing Interval [AUC(TAU)] of multiple dose BMS-986090 SC
timeFrame: Days 1 -106
measure: Trough observed plasma concentration (Ctrough) of multiple dose BMS-986090 SC
timeFrame: Days 1 -106
measure: Average concentration over a dosing interval (Css-avg) of multiple dose BMS-986090 SC
timeFrame: Days 1 -106
measure: Degree of Fluctuation (DF) of multiple dose BMS-986090 SC
timeFrame: Days 1 -106
measure: AUC accumulation index (AI_AUC); ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose of BMS-986090 SC (multiple dose)
timeFrame: Days 1 -106
measure: Cmax accumulation index (AI_Cmax); ratio of Cmax at steady state to Cmax after the first dose of BMS-986090 SC (multiple dose)
timeFrame: Days 1 -106
measure: Apparent total body clearance (CLT/F) of multiple dose BMS-986090 SC
timeFrame: Days 1 -106
measure: Anti-KLH immunoglobulin G (IgG) and IgM antibody levels of single dose BMS-986090 SC
timeFrame: Days 1 -85
measure: Immunogenicity of BMS-986090 following single SC / IV infusion measured by frequency of subjects with positive anti-drug-antibody (ADA) assessment and frequency of subjects who develop positive ADA following a negative baseline
timeFrame: Days 1 -85
measure: Receptor occupancy (RO) of BMS-986090 following single SC or IV infusion
timeFrame: Days 1 -85
Other outcomes:
Locations:
city: Glendale
country: United States
facility: California Clinical Trials Medical Group
state: California
city: Baltimore
country: United States
facility: Parexel Baltimore Early Phase Clinical Unit
state: Maryland
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: