Study identifier:D3820C00009
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
Renal Impairment
Phase 1
Yes
NKTR118 Group1, NKTR118 Group 2, NKTR118 Group3, NKTR118
All
32
Interventional
18 Years - 80 Years
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Oct 2014 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: NKTR118 Group1 Normal Renal Function | Drug: NKTR118 Group1 Oral dose, 25 mg |
Experimental: NKTR118 Group 2 Moderate Renal Function | Drug: NKTR118 Group 2 Oral dose, 25 mg |
Experimental: NKTR118 Group 3 Severe Renal Impairment | Drug: NKTR118 Group3 Oral dose, 25 mg |
Experimental: NKTR118 Group 4 End-Stage Renal Disease | Drug: NKTR118 Oral dose, 25 mg |