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

Completed · Phase 1

Conditions studied: Hepatic; Functional Disturbance

In brief

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.

Key facts

Study ID

NCT01392807

Run by

AstraZeneca

People needed

24

Starts

2011-07-01

Expected to finish

2011-11-01

Last updated by the study team

2014-10-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Research Site — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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