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

AstraZeneca

Status and phase: Terminated; Phase 1

Conditions: Healthy Male

Treatments: Other: Placebo comparator; Drug: TC-5214; Other: Moxifloxacin placebo comparator; Drug: Moxifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01359618

D4130C00009

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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16 participants in 6 patient groups, including a placebo group

Part A 1

Experimental group

Description:

TC-5214

Treatment:

Drug: TC-5214

Part A 2

Experimental group

Description:

TC-5214 placebo

Treatment:

Other: Placebo comparator

Part B 1

Experimental group

Description:

TC-5214 8 mg + moxifloxacin placebo

Treatment:

Drug: TC-5214

Other: Moxifloxacin placebo comparator

Part B 2

Experimental group

Description:

TC-5214 supratherapeutic dose + moxifloxacin placebo

Treatment:

Drug: TC-5214

Other: Moxifloxacin placebo comparator

Part B 3

Active Comparator group

Description:

TC-5214 placebo + moxifloxacin 400 mg

Treatment:

Drug: Moxifloxacin

Other: Placebo comparator

Part B 4

Placebo Comparator group

Description:

TC-5214 placebo + moxifloxacin placebo

Treatment:

Other: Moxifloxacin placebo comparator

Other: Placebo comparator