Clinical trial NCT01708889: Pharmacokinetic Study of BMS-914143 in Participants With Normal Renal Function and Mild, Moderate, Severe and End-stage Renal Dysfunction
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis B Virus Infection
Chronic Hepatitis C Virus Infection
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-10-17
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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

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

Primary outcomes:
measure: 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
timeFrame: 18 time points up to Day 29
measure: 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
timeFrame: 18 time points up to Day 29
measure: 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
timeFrame: 18 time points up to Day 29
measure: 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
timeFrame: 18 time points up to Day 29
measure: 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
timeFrame: 18 time points up to Day 29
Secondary outcomes:
measure: Time to maximum observed serum concentration (Tmax) using serum levels of Lambda
timeFrame: 18 time points up to Day 29
measure: Half life (T-HALF) using serum levels of Lambda
timeFrame: 18 time points up to Day 29
measure: Immunogenicity assessed by serum levels of anti-Lambda antibodies
timeFrame: 5 time points up to Day 43
measure: Safety assessed by Vital signs measurements, electrocardiograms (ECGs), clinical laboratory tests, marked laboratory abnormalities, physical measurements, and adverse events (AEs)
timeFrame: Up to Day 43
measure: Serious adverse events (SAEs) Safety assessed by Vital signs measurements, electrocardiograms (ECGs), clinical laboratory tests, marked laboratory abnormalities, physical measurements, and adverse events (AEs)
timeFrame: Approximately up to Day 73
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology Of Miami Inc.
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Knoxville
country: United States
facility: New Orleans Center For Clinical Research - Knoxville
state: Tennessee
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: