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
  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 April 15, 2014