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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014