Assessing the pharmacokinetics of NKTR-118 in subjects with renal impairment compared to that in subjects with normal renal function

Study identifier:D3820C00009

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An Open-Label, Parallel-Group, Phase I Study to Compare the Pharmacokinetics of NKTR-118 Following a Single Oral Dose in Subjects with Renal Impairment and Subjects with Normal Renal Function

Medical condition

Renal Impairment

Phase

Phase 1

Healthy volunteers

Yes

Study drug

NKTR118 Group1, NKTR118 Group 2, NKTR118 Group3, NKTR118

Sex

All

Actual Enrollment

32

Study type

Interventional

Age

18 Years - 80 Years

Date

Study Start Date: 01 Jun 2011
Primary Completion Date: 01 Oct 2011
Study Completion Date: 01 Nov 2011

Study design

Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Oct 2014 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria