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
45
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
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| 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 |
Contacts
Investigators
Principal Investigator
Mark Sostek
AstraZeneca, Wilmington US
