Open-label Study to Assess the Pharmacokinetics of NKTR-118 in Patients With Impaired Hepatic Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-11-30

Brief Summary

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The purpose of this study is to assess the pharmacokinetics of NKTR-118 in patients with impaired hepatic function versus subjects with normal hepatic function.

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Detailed Description

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Conditions

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Hepatic; Functional Disturbance

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group 1

Normal hepatic function, 25 mg NKTR-118 administered orally

Group Type EXPERIMENTAL

NKTR-118

Intervention Type DRUG

25 mg Oral tablets, single dose

Group 2

Mild hepatic impairment, 25 mg NKTR-118 administered orally

Group Type EXPERIMENTAL

NKTR-118

Intervention Type DRUG

25 mg Oral tablets, single dose

Group 3

Moderate hepatic impairment, 25 mg NKTR-118 administered orally

Group Type EXPERIMENTAL

NKTR-118

Intervention Type DRUG

25 mg Oral tablets, single dose

Interventions

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NKTR-118

25 mg Oral tablets, single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males or females aged 18 years or more with a weight of at least 50 kg and BMI between 18 and 40 kg/m2, inclusive.
* Negative screen for human immunodeficiency virus (HIV)
* For subjects with normal hepatic function, negative results for serum hepatitis B (HBV) surface antigen, HCV antibody, and HIV

Exclusion Criteria

* Plasma or blood product donation within 1 month of screening or any blood donation/blood loss greater than 500 mL during the 3 months prior to screening.
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity
* Known or suspected history of drug/chemical abuse within the past 2 years as judged by the Investigator.
* Subjects with a history of surgery on the gastrointestinal tract.
* For patients with hepatic impairment, fluctuating or rapidly deteriorating hepatic function as indicated by clinical and/or laboratory signs of hepatic impairment (e.g. advanced ascites, infection of ascites, fever, or active gastrointestinal bleeding).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes