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Completed

NCT Number: 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

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))

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Key information

Conditions

Amount of NKTR-118 in Blood Variation in the Heart's Electrical Cycle

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Overland Park, Kansas, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NKTR-118

Drug

25 mg tablet

moxifloxacin

Drug

400 mg tablet

Placebo

Drug

tablet

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 29, 2011
Registry last updated
Oct 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.