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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

NCT01325415 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2014-10-15

No results posted yet for this study

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))

Conditions

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

Interventions

DRUG

NKTR-118

25 mg tablet

DRUG

moxifloxacin

400 mg tablet

DRUG

Placebo

tablet

Sponsors & Collaborators

Principal Investigators

  • Mark Sostek, MD · AstraZeneca, Wilmington US

  • David Matthews, MD · Quintiles, Overland Park Kansas US

  • Emilie Ramos, MD · AstraZeneca, Alderley Park, UK

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01325415 on ClinicalTrials.gov