Study identifier:D3820C00010
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
Hepatic; Functional Disturbance
Phase 1
Yes
NKTR-118
All
24
Interventional
18 Years +
Allocation: Non-randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Oct 2014 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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No locations available
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 |