Clinical trial NCT01325415: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Amount of NKTR-118 in Blood
Variation in the Heart's Electrical Cycle
Keywords: Phase 1
healthy male volunteers
cross-over study
NKTR-118
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-03-29
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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))

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 30 days pre-dose through 4 treatment periods and follow up 71 days post dose.
measure: 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
timeFrame: Follow up 71 days post dose.
Secondary outcomes:
measure: 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.
timeFrame: 30 days pre-dose through 4 treatment periods
measure: Collect adverse events to assess the safety after dosing of NKTR-118 25mg and 150 mg in healthy male subjects.
timeFrame: 30 days pre-dose through 4 treatment periods
measure: 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.
timeFrame: Follow up 71 days post dose
measure: Collect adverse events to assess the safety after dosing of NKTR-118 25mg and 150mg in healthy male subjects.
timeFrame: Follow up 71 days post dose.
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Research Site
state: Kansas
Study officials:
affiliation: AstraZeneca, Wilmington US
name: Mark Sostek, MD
role: STUDY_DIRECTOR
affiliation: Quintiles, Overland Park Kansas US
name: David Matthews, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca, Alderley Park, UK
name: Emilie Ramos, MD
role: STUDY_CHAIR
References:
citation: 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.