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

July 8, 2011
January 13, 2012
July 2011
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT01392807 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Open-label Study to Assess the Pharmacokinetics of NKTR-118 in Patients With Impaired Hepatic Function
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

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Hepatic; Functional Disturbance
Drug: NKTR-118
25 mg Oral tablets, single dose
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
November 2011
Not Provided

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).
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01392807
D3820C00010
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Mark Sostek, MD AstraZeneca
Principal Investigator: Thomas Marbury, MD Orlando Clinical Research Center
Study Chair: Bo Fransson, MD AstraZeneca
AstraZeneca
January 2012

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