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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01392807

First received: July 8, 2011

Last updated: January 13, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 8, 2011

Last Updated Date

January 13, 2012

Start Date ^ICMJE

July 2011

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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) [ Time Frame: Duration from predose day 1 to day 6. ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01392807 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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. [ Time Frame: Duration from day -1 to follow up. ( Approximately 15-18 days) ] [ Designated as safety issue: Yes ]
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 [ Time Frame: Duration from day -1 to follow up. ( Approximately 15-18 days) ] [ Designated as safety issue: Yes ]
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 [ Time Frame: Duration from day -1 to follow up. ( Approximately 15-18 days) ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Open-label, Single-center Study to Assess the Pharmacokinetics of NKTR-118 in Patients With Impaired Hepatic Function and Subjects With Normal Hepatic Function Following Administration of a Single Dose of 25mg NKTR-118

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Hepatic; Functional Disturbance

Intervention ^ICMJE

Drug: NKTR-118

25 mg Oral tablets, single dose

Study Arm (s)

Experimental: Group 1
Normal hepatic function, 25 mg NKTR-118 administered orally

Intervention: Drug: NKTR-118
Experimental: Group 2
Mild hepatic impairment, 25 mg NKTR-118 administered orally

Intervention: Drug: NKTR-118
Experimental: Group 3
Moderate hepatic impairment, 25 mg NKTR-118 administered orally

Intervention: Drug: NKTR-118

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2011

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01392807

Other Study ID Numbers ^ICMJE

D3820C00010

Has Data Monitoring Committee

Not Provided

Responsible Party

AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:	Mark Sostek, MD	AstraZeneca
Principal Investigator:	Thomas Marbury, MD	Orlando Clinical Research Center
Study Chair:	Bo Fransson, MD	AstraZeneca

Information Provided By

AstraZeneca

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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