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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01325415
First received: March 28, 2011
Last updated: August 9, 2011
Last verified: August 2011

March 28, 2011
August 9, 2011
April 2011
July 2011   (final data collection date for primary outcome measure)
  • To evaluate the effect of a single dose of NKTR-118 25 mg and 150 mg on the change in time-matched QTcF intervals compared with placebo [ Time Frame: 30 days pre-dose through 4 treatment periods and follow up 71 days post dose. ] [ Designated as safety issue: Yes ]
  • The effect of a single dose of NKTR-118 25 mg and 150 mg on the change in time-matched QTcF intervals compared with placebo [ Time Frame: Follow up 71 days post dose. ] [ Designated as safety issue: Yes ]
  • To evaluate the effect of a single dose of NKTR-118 25 mg and 150 mg on the change in time-matched QTcF intervals compared with placebo [ Time Frame: 30 days pre-dose through 4 treatment periods and follow up 71 days post dose. ]
  • The effect of a single dose of NKTR-118 25 mg and 150 mg on the change in time-matched QTcF intervals compared with placebo [ Time Frame: Follow up 71 days post dose. ]
Complete list of historical versions of study NCT01325415 on ClinicalTrials.gov Archive Site
  • To evaluate the effect of a single oral dose of moxifloxacin 400 mg on the changes in time-match QTcF intervals compared with placebo, which will be used as supporting data. [ Time Frame: 30 days pre-dose through 4 treatment periods ] [ Designated as safety issue: Yes ]
  • Collect adverse events to assess the safety after dosing of NKTR-118 25mg and 150 mg in healthy male subjects. [ Time Frame: 30 days pre-dose through 4 treatment periods ] [ Designated as safety issue: Yes ]
  • To evaluate the effect of a single oral dose of moxifloxacin 400 mg on the changes in time-match QTcF intervals compared with placebo, which will be used as supporting data. [ Time Frame: Follow up 71 days post dose ] [ Designated as safety issue: Yes ]
  • Collect adverse events to assess the safety after dosing of NKTR-118 25mg and 150mg in healthy male subjects. [ Time Frame: Follow up 71 days post dose. ] [ Designated as safety issue: Yes ]
  • To evaluate the effect of a single oral dose of moxifloxacin 400 mg on the changes in time-match QTcF intervals compared with placebo, which will be used as supporting data. [ Time Frame: 30 days pre-dose through 4 treatment periods ]
  • Collect adverse events to assess the safety after dosing of NKTR-118 25mg and 150 mg in healthy male subjects. [ Time Frame: 30 days pre-dose through 4 treatment periods ]
  • To evaluate the effect of a single oral dose of moxifloxacin 400 mg on the changes in time-match QTcF intervals compared with placebo, which will be used as supporting data. [ Time Frame: Follow up 71 days post dose ]
  • Collect adverse events to assess the safety after dosing of NKTR-118 25mg and 150mg in healthy male subjects. [ Time Frame: Follow up 71 days post dose. ]
Not Provided
Not Provided
 
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
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

The purpose of this study is to evaluate the effects on QTc interval in healthy males when administered a single dose of NKTR-118 compared with placebo and moxifloxacin. (QTc is a specific time interval that can be measured in a heart beat by taking Electrocardiogram (ECG))

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
  • Amount of NKTR-118 in Blood
  • Variation in the Heart's Electrical Cycle
  • Drug: NKTR-118
    25 mg tablet
  • Drug: moxifloxacin
    400 mg tablet
  • Drug: Placebo
    tablet
  • Experimental: A
    NKTR-118 25 mg (1x25 mg tablet + 5x placebo tablets)
    Interventions:
    • Drug: NKTR-118
    • Drug: Placebo
  • Experimental: B
    NKTR-118 150 mg (6x25 mg tablet)
    Interventions:
    • Drug: NKTR-118
    • Drug: Placebo
  • Placebo Comparator: C
    NKTR-118 placebo (6x placebo tablets)
    Intervention: Drug: Placebo
  • Active Comparator: D
    Moxifloxacin (1 x 400 mg tablet)
    Intervention: Drug: moxifloxacin
Gottfridsson C, Carlson G, Lappalainen J, Sostek M. Evaluation of the effect of Naloxegol on cardiac repolarization: a randomized, placebo- and positive-controlled crossover thorough QT/QTc study in healthy volunteers. Clin Ther. 2013 Dec;35(12):1876-83. doi: 10.1016/j.clinthera.2013.09.019. Epub 2013 Nov 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male subjects aged 18 to 50 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
  • Body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and weight at least 50 kg but no more than 100 kg.

Exclusion Criteria:

  • Clinically significant medical history including severe allergies or a history of mental disorders or any cardiac history, history or presence of gastrointestinal, hepatic, or renal disease.
  • Abnormal heart rhythm including any abnormal arrhythmias, marked sinus arrhythmias, or junctional rhythms.
  • Known or suspected history of drug abuse, current smokers or those who have smoked and/or used nicotine products within 3 months prior to enrollment.
  • Excessive intake of caffeine-containing products
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01325415
D3820C00014
No
Mark Sostek / Medical Science Director, AstraZeneca
AstraZeneca
Not Provided
Study Director: Mark Sostek, MD AstraZeneca, Wilmington US
Principal Investigator: David Matthews, MD Quintiles, Overland Park Kansas US
Study Chair: Emilie Ramos, MD AstraZeneca, Alderley Park, UK
AstraZeneca
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP