single and multiple ascending dose study for NKTR-118 and cross-over study to investigate the effect of food for NKTR-118 in Japanese healthy subjects - Japan SMAD
Study identifier:D3820C00020
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of NKTR-118 following single and multiple ascending oral dose administration in healthy young and elderly Japanese subjects, and an Open Randomized, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics after single oral doses of NKTR-118 in healthy male Japanese subjects
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
NKTR-118, Placebo
Sex
All
Actual Enrollment
50
Study type
Interventional
Age
20 Years - 80 Years
Date
Study Start Date: 01 Mar 2011
Primary Completion Date: 01 Jul 2011
Study Completion Date: 01 Jul 2011
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Oct 2014 by AStraZeneca
Sponsors
AStraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: NKTR-118 | Drug: NKTR-118 Tablet, Oral, Once daily |
| Placebo Comparator: Placebo | Drug: Placebo Tablet, Oral, Once daily |
Contacts
Investigators
Principal Investigator
Mark Sostek
AstraZeneca
