Pharmacokinetics of Peginterferon Alfa-2b in Participants With Moderate and Severe Renal Impairment (P05655)

A Single Dose Study to Assess Pharmacokinetics of SCH 54031 in Patients With Renal Impairment (P05655)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01432535

Enrollment

Registered

2011-09-13

Start date

2011-11-30

Completion date

2012-08-31

Last updated

2017-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Insufficiency

Brief summary

This study will compare the pharmacokinetics of a single dose of peginterferon alfa-2b (Sylatron®) in healthy participants to that in participants with moderate to severe impairment of kidney function.

Interventions

DRUGPegIFN-2b (Sylatron®)

Single 4.5 μg/kg dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

Yes

Inclusion criteria

* Body Mass Index (BMI) between 19 to 40 kg/m\^2, inclusive * Moderate renal impairment and severe renal impairment and/or end-stage renal disease (ESRD) who may require hemodialysis and normal renal function * Free of any clinically significant disease (except those related to renal disease and comorbid conditions) that requires a physician's care and would interfere with the study * Females of reproductive potential must have used a medically accepted method of contraception for three months prior to screening and must agree to use an accepted contraceptive method during and for two months following the study * Males must agree to use a medically accepted method of contraception during the trial and for 3 months after the study

Exclusion criteria

* Pregnant, intend to become pregnant, or breastfeeding * Surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug * History of any infectious disease within 4 weeks prior to study drug administration that affects ability to participate in the study * Positive for hepatitis B surface antigen, and/or for human immunodeficiency virus (HIV) antibodies. Healthy participants positive for hepatitis C antibodies * Previously received PegIntron®, Sylatron®, and/or Pegasys * More than 10 cigarettes or equivalent tobacco use per day * History of malignancy * Hypothyroidism or hyperthyroidism * History of depression requiring treatment with psychotherapy or medication * History of suicidality or at risk of self-harm or harm to others * History of autoimmune disorder requiring medical therapy * Immune mediated renal insufficiency * Removal of a kidney (healthy participants) or functioning renal transplant (participants with renal impairment)

Design outcomes

Primary

Measure	Time frame	Description
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞)	From hour 0 (pre-dose) to 288 hours post-dose	AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.
AUC From Time 0 to the Last Measurable Sample (AUC0-last)	From hour 0 (pre-dose) up to 288 hours post-dose	AUC0-last is a measure of the total amount of drug in the plasma from the dose to the last measurable sample.
Maximum Observed Serum Concentration (Cmax)	From hour 0 (pre-dose) to 288 hours post-dose	Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.
Time to Maximum Observed Serum Concentration (Tmax)	From hour 0 (pre-dose) up to 288 hours post-dose	Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose.
Apparent Terminal Half-life (T1/2)	From hour 0 (pre-dose) up to 288 hours post-dose	T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.
Apparent Total Body Clearance (CL/F)	From hour 0 (pre-dose) up to 288 hours post-dose	CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes).
Apparent Volume of Distribution (Vd/F)	From hour 0 (pre-dose) up to 288 hours post-dose	Vd/F is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug.

Participant flow

Participants by arm

Arm	Count
Healthy Participants Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.	12
Participants With Moderate Renal Impairment Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.	6
Participants With Severe Renal Impairment Participants with severe renal impairment defined as having a creatinine clearance test value of \<30 mL/min/1.73 m\^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.	6
Total	24

Baseline characteristics

Characteristic	Healthy Participants	Participants With Moderate Renal Impairment	Participants With Severe Renal Impairment	Total
Age, Continuous	57.33 Years STANDARD_DEVIATION 9.63	64.00 Years STANDARD_DEVIATION 6.23	52.67 Years STANDARD_DEVIATION 12.74	57.83 Years STANDARD_DEVIATION 10.25
Sex: Female, Male Female	1 Participants	0 Participants	1 Participants	2 Participants
Sex: Female, Male Male	11 Participants	6 Participants	5 Participants	22 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	12 / 12	7 / 7	6 / 6
serious Total, serious adverse events	0 / 12	0 / 7	1 / 6

Outcome results

Primary