Pharmacokinetic Study of BMS-914143 in Participants With Normal Renal Function and Mild, Moderate, Severe and End-stage Renal Dysfunction (PK)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis B Virus Infection; Chronic Hepatitis C Virus Infection

Treatments: Biological: BMS-914143 (Peginterferon Lambda-1a)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01708889

AI452-019

Details and patient eligibility

About

The purpose of this study is to determine the effect of renal impairment on pharmacokinetics (PK) of BMS-914143.

Full description

Primary purpose: Protocol designed to evaluate the effect of renal impairment on pharmacokinetics of BMS-914143

Enrollment: 43 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

43 participants in 5 patient groups

Group 1: BMS-914143 (eGFR ≥ 80 mL/min/1.73 m2)

Experimental group

Description:

BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with normal renal function with eGFR ≥ 80 mL/min/1.73 m2

Treatment:

Biological: BMS-914143 (Peginterferon Lambda-1a)

Group 2: BMS-914143 (eGFR 60 to 79 mL/min/1.73 m2)

Experimental group

Description:

BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with mild renal dysfunction with eGFR 60 to 79 mL/min/1.73 m2

Treatment:

Biological: BMS-914143 (Peginterferon Lambda-1a)

Group 3: BMS-914143 (eGFR 30 to 59 mL/min/1.73 m2)

Experimental group

Description:

BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with moderate renal dysfunction with eGFR 30 to 59 mL/min/1.73 m2

Treatment:

Biological: BMS-914143 (Peginterferon Lambda-1a)

Group 4: BMS-914143 (eGFR 15 to 29 mL/min/1.73 m2)

Experimental group

Description:

BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with severe renal dysfunction with eGFR 15 to 29 mL/min/1.73 m2

Treatment:

Biological: BMS-914143 (Peginterferon Lambda-1a)

Group 5: BMS-914143 (eGFR < 15 mL/min/1.73 m2)

Experimental group

Description:

BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with end-stage renal dysfunction with eGFR \< 15 mL/min/1.73 m2 (on hemodialysis \[HD\] or non-HD)

Treatment:

Biological: BMS-914143 (Peginterferon Lambda-1a)