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

Completed · Phase 1 · Has a placebo group

Conditions studied: Amount of NKTR-118 in Blood, Variation in the Heart's Electrical Cycle

In brief

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))

Key facts

Study ID

NCT01325415

Run by

AstraZeneca

People needed

45

Starts

2011-04-01

Expected to finish

2011-07-01

Last updated by the study team

2014-10-15

Who can join

Age: 18 and older, up to 50. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Research Site — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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