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Determining Highest Dose Administration of TC-5214 and Evaluating Effect on the Electrical Activity in the Heart

NCT01359618 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2012-12-12

No results posted yet for this study

Summary

This is a two part study. Part A will determine the maximum tolerated dose of TC-5214 administered to healthy male subjects in single ascending oral doses. This part of the study will define the highest dose of TC-5214 to be administered in Part B. Part B of this study will investigate the effect of TC-5214 on the electrical activity of the heart following single oral administration. The study will be carried out healthy male subjects in a four period crossover study with TC-5214 compared to placebo and oral moxifloxacin as a positive control. The safety, tolerability and pharmacokinetics of TC-5214 will also be evaluated.

Conditions

  • Healthy Male

Interventions

DRUG

TC-5214

Single dose, oral tablets

OTHER

Placebo comparator

Single dose, oral tablets

DRUG

Moxifloxacin

Single dose, oral encapsulated tablet

OTHER

Moxifloxacin placebo comparator

Single dose, oral encapsulated tablet

Sponsors & Collaborators

Principal Investigators

  • Hans A Eriksson, MD, PhD, MBA · AstraZeneca

  • Darren Wilbraham, MBBS DCPSA · Quintiles Drug Research Unit at Guy's Hospital

  • Brendan Smyth, MD · AstraZeneca

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
2011-06-30
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United Kingdom

Study Locations

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Entities

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 NCT01359618 on ClinicalTrials.gov