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

Purpose

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.

Condition	Intervention	Phase
Hepatic; Functional Disturbance	Drug: NKTR-118	Phase 1

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	24
Study Start Date:	July 2011
Study Completion Date:	November 2011

Arms	Assigned Interventions
Experimental: Group 1 Normal hepatic function, 25 mg NKTR-118 administered orally	Drug: NKTR-118 25 mg Oral tablets, single dose
Experimental: Group 2 Mild hepatic impairment, 25 mg NKTR-118 administered orally	Drug: NKTR-118 25 mg Oral tablets, single dose
Experimental: Group 3 Moderate hepatic impairment, 25 mg NKTR-118 administered orally	Drug: NKTR-118 25 mg Oral tablets, single dose

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392807

Locations

United States, Kansas
Research Site
Overland Park, Kansas, United States

Sponsors and Collaborators

AstraZeneca

Investigators

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

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01392807 History of Changes
Other Study ID Numbers:	D3820C00010
Study First Received:	July 8, 2011
Last Updated:	January 13, 2012
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by AstraZeneca:

Phase 1
volunteers with hepatic impairment
pharmacokinetics
NKTR-118
Child-Pugh scale

AUC
Cmax
tmax
t1/2

ClinicalTrials.gov processed this record on June 18, 2013