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

NCT ID: NCT01359618

Last Updated: 2012-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Male

Keywords

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Phase I Safety tolerability healthy major depressive disorder thorough QT maximum tolerated dose elimination heart electrical signal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part A 1

TC-5214

Group Type EXPERIMENTAL

TC-5214

Intervention Type DRUG

Single dose, oral tablets

Part A 2

TC-5214 placebo

Group Type EXPERIMENTAL

Placebo comparator

Intervention Type OTHER

Single dose, oral tablets

Part B 1

TC-5214 8 mg + moxifloxacin placebo

Group Type EXPERIMENTAL

TC-5214

Intervention Type DRUG

Single dose, oral tablets

Moxifloxacin placebo comparator

Intervention Type OTHER

Single dose, oral encapsulated tablet

Part B 2

TC-5214 supratherapeutic dose + moxifloxacin placebo

Group Type EXPERIMENTAL

TC-5214

Intervention Type DRUG

Single dose, oral tablets

Moxifloxacin placebo comparator

Intervention Type OTHER

Single dose, oral encapsulated tablet

Part B 3

TC-5214 placebo + moxifloxacin 400 mg

Group Type ACTIVE_COMPARATOR

Placebo comparator

Intervention Type OTHER

Single dose, oral tablets

Moxifloxacin

Intervention Type DRUG

Single dose, oral encapsulated tablet

Part B 4

TC-5214 placebo + moxifloxacin placebo

Group Type PLACEBO_COMPARATOR

Placebo comparator

Intervention Type OTHER

Single dose, oral tablets

Moxifloxacin placebo comparator

Intervention Type OTHER

Single dose, oral encapsulated tablet

Interventions

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TC-5214

Single dose, oral tablets

Intervention Type DRUG

Placebo comparator

Single dose, oral tablets

Intervention Type OTHER

Moxifloxacin

Single dose, oral encapsulated tablet

Intervention Type DRUG

Moxifloxacin placebo comparator

Single dose, oral encapsulated tablet

Intervention Type OTHER

Other Intervention Names

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Avelox®

Eligibility Criteria

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Inclusion Criteria

* Healthy male 18 to 50 years old inclusive with suitable veins for cannulation or repeated venipuncture
* Have a body mass index (BMI) between 19 and 30 kg/m2 inclusive and weigh at least 50 kg
* Male subjects should be willing to use a double barrier method of contraception (condom with spermicide) from the first dose of investigational product until 3 months after the last dose of investigational product
* Be able to understand and comply with the requirements of the study as judged by the investigator

Exclusion Criteria

* History of any clinically significant medical, neurologic or psychiatric disease or disorder which, in the opinion of the Investigator and Sponsor may either put the subject at risk because of participation in the study, or influence the results of the subject's ability to participate in the study
* History or presence of gastrointestinal (including irritable bowel disease), hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of study drug. Subjects with a history of surgery on the gastrointestinal tract (not including appendectomy or cholecystectomy) should also be excluded
* History of seizure activity, including febrile seizures
* Prolonged QTcF \>450 ms or shortened QTcF \<340 ms, or family history of Long QT Syndrome
* Use of concomitant medications that prolong QT/QTc interval
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hans A Eriksson, MD, PhD, MBA

Role: STUDY_DIRECTOR

AstraZeneca

Darren Wilbraham, MBBS DCPSA

Role: PRINCIPAL_INVESTIGATOR

Quintiles Drug Research Unit at Guy's Hospital

Brendan Smyth, MD

Role: STUDY_CHAIR

AstraZeneca

Locations

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Research Site

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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D4130C00009

Identifier Type: -

Identifier Source: org_study_id