Chronic Hepatitis B Virus Infection, Chronic Hepatitis C Virus Infection
Conditions
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
Interventions
BIOLOGICALBMS-914143 (Peginterferon Lambda-1a)
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 18 time points up to Day 29 |
| 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 | 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 | 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 | 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 | 18 time points up to Day 29 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed