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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Hepatic; Functional Disturbance

Treatments: Drug: NKTR-118

Study type: Interventional

Funder types: Industry

Identifiers

NCT01392807

D3820C00010

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Group 1

Experimental group

Description:

Normal hepatic function, 25 mg NKTR-118 administered orally

Treatment:

Drug: NKTR-118

Group 2

Experimental group

Description:

Mild hepatic impairment, 25 mg NKTR-118 administered orally

Treatment:

Drug: NKTR-118

Group 3

Experimental group

Description:

Moderate hepatic impairment, 25 mg NKTR-118 administered orally

Treatment:

Drug: NKTR-118