Study to Evaluate the Safety, Tolerability, PK, and PD of BMS-986090 in Healthy Subjects

Healthy Adult Volunteers Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02079480
• Other study ID #: IM142-003
• Status: Terminated
• Phase: Phase 1
• First received: March 4, 2014
• Last updated: May 3, 2016
• Start date: May 2014
• Est. completion date: April 2016

Study information

• Verified date: March 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Adult Volunteers

Intervention

Drug:
• BMS-986090

• Placebo matching with BMS-986090

• Keyhole limpet hemocyanin

Locations

Country	Name	City	State
United States	Parexel Baltimore Early Phase Clinical Unit	Baltimore	Maryland
United States	California Clinical Trials Medical Group	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	AE = Adverse event; ECG = Electrocardiogram	Up to Day 85 after single dose of BMS-986090	Yes
Primary	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		Up to Day 106 after multiple dose of BMS-986090	Yes
Secondary	Maximum observed serum concentration (Cmax) of BMS-986090 single dose subcutaneous (SC) and intravenous (IV)		Days 1 -85	No
Secondary	Time of maximum observed serum concentration (Tmax) of single dose BMS-986090 SC and IV		Days 1 -85	No
Secondary	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		Days 1 -85	No
Secondary	Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of single dose BMS-986090 SC and IV		Days 1 -85	No
Secondary	Terminal serum half-life (T-HALF) of single dose BMS-986090 SC and IV		Days 1 -85	No
Secondary	Total body clearance (CLT) of single dose BMS-986090 IV		Days 1 -85	No
Secondary	Apparent total body clearance (CLT/F) of single dose BMS-986090 SC		Days 1 -85	No
Secondary	Volume of distribution at terminal phase (Vz) of single dose BMS-986090 IV		Days 1 -85	No
Secondary	Volume of distribution during steady state (Vss) of single dose BMS-986090 IV		Days 1 -85	No
Secondary	Apparent volume of distribution at terminal phase (Vz/F) of single dose BMS-986090 SC		Days 1 -85	No
Secondary	Absolute bioavailability (F) of single dose BMS-986090 SC		Days 1 -85	No
Secondary	Maximum observed serum concentration (Cmax) of multiple dose BMS-986090 SC		Days 1 -106	No
Secondary	Time of maximum observed serum concentration (Tmax) of multiple dose BMS-986090 SC		Days 1 -106	No
Secondary	Terminal serum half-life (T-HALF) of multiple dose BMS-986090 SC		Days 1 -106	No
Secondary	Area under the serum concentration-time curve in one dosing Interval [AUC(TAU)] of multiple dose BMS-986090 SC		Days 1 -106	No
Secondary	Trough observed plasma concentration (Ctrough) of multiple dose BMS-986090 SC		Days 1 -106	No
Secondary	Average concentration over a dosing interval (Css-avg) of multiple dose BMS-986090 SC		Days 1 -106	No
Secondary	Degree of Fluctuation (DF) of multiple dose BMS-986090 SC		Days 1 -106	No
Secondary	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)		Days 1 -106	No
Secondary	Cmax accumulation index (AI_Cmax); ratio of Cmax at steady state to Cmax after the first dose of BMS-986090 SC (multiple dose)		Days 1 -106	No
Secondary	Apparent total body clearance (CLT/F) of multiple dose BMS-986090 SC		Days 1 -106	No
Secondary	Anti-KLH immunoglobulin G (IgG) and IgM antibody levels of single dose BMS-986090 SC		Days 1 -85	No
Secondary	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		Days 1 -85	No
Secondary	Receptor occupancy (RO) of BMS-986090 following single SC or IV infusion		Days 1 -85	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form