An Open-label, Single Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-914143 in Subject With Normal Renal Function and Subjects With Mild, Moderate, Severe, and End-stage Renal Dysfunction
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic Hepatitis B Virus Infection
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 43
- Locations
- 3
- Primary Endpoint
- Area under the serum concentration-time curve from time 0 extrapolated to infinity [AUC(INF)] of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to determine the effect of renal impairment on pharmacokinetics (PK) of BMS-914143.
Detailed Description
Primary purpose: Protocol designed to evaluate the effect of renal impairment on pharmacokinetics of BMS-914143
Investigators
Eligibility Criteria
Inclusion Criteria
- •Normal renal function or mild, moderate, severe or end-stage renal dysfunction
Exclusion Criteria
- •History of uncontrolled or unstable cardiovascular, respiratory, gastrointestinal, hepatic, endocrine, hematopoietic, psychiatric or neurological conditions within 6 months of Lambda administration
- •History of chronic liver disease including cirrhosis, hepatitis B virus (HBV), hepatitis C virus (HCV), primary biliary cirrhosis, etc
- •History of central nervous system or neuro-psychiatric disease. Subjects with severe depression and/or other uncontrolled psychiatric conditions should not be enrolled in this study
- •History of of suicide attempt within the 5 years preceding BMS-914143 administration
- •Inability to tolerate subcutaneous injections
- •Donation of \>400 mL of blood within 8 weeks or plasma within 4 weeks of planned dosing
Outcomes
Primary Outcomes
Area under the serum concentration-time curve from time 0 extrapolated to infinity [AUC(INF)] of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
Time Frame: 18 time points up to Day 29
Area under the serum concentration-time curve from time 0 to the time of last quantifiable concentration [AUC(0-T)] of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
Time Frame: 18 time points up to Day 29
Maximum observed serum concentration (Cmax) of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
Time Frame: 18 time points up to Day 29
Apparent volume of distribution (Vz/F) of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
Time Frame: 18 time points up to Day 29
Total body clearance (CLT/F) of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
Time Frame: 18 time points up to Day 29
Secondary Outcomes
- Time to maximum observed serum concentration (Tmax) using serum levels of Lambda(18 time points up to Day 29)
- Half life (T-HALF) using serum levels of Lambda(18 time points up to Day 29)
- Immunogenicity assessed by serum levels of anti-Lambda antibodies(5 time points up to Day 43)
- Safety assessed by Vital signs measurements, electrocardiograms (ECGs), clinical laboratory tests, marked laboratory abnormalities, physical measurements, and adverse events (AEs)(Up to Day 43)
- Serious adverse events (SAEs) Safety assessed by Vital signs measurements, electrocardiograms (ECGs), clinical laboratory tests, marked laboratory abnormalities, physical measurements, and adverse events (AEs)(Approximately up to Day 73)