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

Phase 1

Completed

• Conditions: Hepatic; Functional Disturbance
• Interventions: Drug: NKTR-118

• Registration Number: NCT01392807
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-08
• Study First Submitted QC: 2011-07-12
• Study First Posted: 2011-07-13
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-13
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	NKTR-118	Normal hepatic function, 25 mg NKTR-118 administered orally
Group 2	NKTR-118	Mild hepatic impairment, 25 mg NKTR-118 administered orally
Group 3	NKTR-118	Moderate hepatic impairment, 25 mg NKTR-118 administered orally

Primary Outcome Measures

Name	Time	Method
To assess the pharmacokinetics of a single dose of NKTR-118 25 mg by assessment of area under the curve over the time (AUC) and maximum concentration (Cmax)	Duration from predose day 1 to day 6.

Secondary Outcome Measures

Name	Time	Method
To examine the safety and tolerability of a single oral dose of 25 mg NKTR-118 in patients with impaired hepatic function and in subjects with normal hepatic function by collecting adverse events.	Duration from day -1 to follow up. ( Approximately 15-18 days)
To examine the safety and tolerability of a single oral dose of 25 mg NKTR-118 in patients with impaired hepatic function by collecting safety blood samples	Duration from day -1 to follow up. ( Approximately 15-18 days)
To examine the safety and tolerability of a single oral dose of 25 mg NKTR-118 in patients with impaired hepatic function and in subjects with normal hepatic function by collecting vital signs	Duration from day -1 to follow up. ( Approximately 15-18 days)

Trial Locations

Locations (1)

Research Site; 🇺🇸 Overland Park, Kansas, United States