A Placebo-controlled Four Way Crossover Study to Asses the Effect of a Single Oral Dose of NKTR-118 on QTc Interval in Healthy Male Subjects

Study identifier:D3820C00014

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Single Center, Randomized, Double-blinded, Placebo-controlled, Open-label, Positive-controlled, Four-way Crossover Study to Assess the Effect of a Single Oral Dose NKTR-118 Administration on QTc Interval Compared to Placebo, Using AVELOX (moxifloxacin) as a Positive Control, in Healthy Male Subjects

Medical condition

Amount of NKTR-118 in blood, variation in the heart’s electrical cycle

Phase

Phase 1

Healthy volunteers

Yes

Study drug

NKTR-118, moxifloxacin, Placebo

Sex

Male

Actual Enrollment

Study type

Interventional

Age

18 Years - 50 Years

Date

Study Start Date: 01 Apr 2011

Primary Completion Date: 01 Jul 2011

Study Completion Date: 01 Jul 2011

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science

Verification:

Verified 01 Oct 2014 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Overland Park, KS, United States

Arms	Assigned Interventions
Experimental: A NKTR-118 25 mg (1x25 mg tablet + 5x placebo tablets)	Drug: NKTR-118 25 mg tablet Drug: Placebo tablet
Experimental: B NKTR-118 150 mg (6x25 mg tablet)	Drug: NKTR-118 25 mg tablet Drug: Placebo tablet
Placebo Comparator: C NKTR-118 placebo (6x placebo tablets)	Drug: Placebo tablet
Active Comparator: D Moxifloxacin (1 x 400 mg tablet)	Drug: moxifloxacin 400 mg tablet

Documents available

D3820C00014 Clinical Study Report Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

001-800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Mark Sostek

AstraZeneca, Wilmington US