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

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

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Chuo-ku, Fukuoka, Japan

Arms	Assigned Interventions
Experimental: NKTR-118	Drug: NKTR-118 Tablet, Oral, Once daily
Placebo Comparator: Placebo	Drug: Placebo Tablet, Oral, Once daily

"There is no result for the study"

Documents available

D3820C00020 Clinical Study Report Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

+81-6-6453-8011

Investigators

Principal Investigator

Mark Sostek

AstraZeneca