- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01359618
Determining Highest Dose Administration of TC-5214 and Evaluating Effect on the Electrical Activity in the Heart
December 11, 2012 updated by: AstraZeneca
A Single-centre, Randomised, Double-blind, Placebo Controlled Phase I Study in Two Parts: Part A to Assess a Safe and Tolerable Supratherapeutic Dose of TC-5214 After Single Ascending Oral Doses in Healthy Male Subjects, Followed by Part B: A Four-period Double-dummy Crossover Study to Investigate the Effect of 2 Single Doses (Therapeutic and Supratherapeutic) of TC-5214 on the QT/QTc Interval, Compared to Placebo, Using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Subjects
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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London, United Kingdom
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part A 1
TC-5214
|
Single dose, oral tablets
|
Experimental: Part A 2
TC-5214 placebo
|
Single dose, oral tablets
|
Experimental: Part B 1
TC-5214 8 mg + moxifloxacin placebo
|
Single dose, oral tablets
Single dose, oral encapsulated tablet
|
Experimental: Part B 2
TC-5214 supratherapeutic dose + moxifloxacin placebo
|
Single dose, oral tablets
Single dose, oral encapsulated tablet
|
Active Comparator: Part B 3
TC-5214 placebo + moxifloxacin 400 mg
|
Single dose, oral encapsulated tablet
Other Names:
Single dose, oral tablets
|
Placebo Comparator: Part B 4
TC-5214 placebo + moxifloxacin placebo
|
Single dose, oral tablets
Single dose, oral encapsulated tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Part A: To examine the safety and tolerability of TC-5214. The following assessments will be measured and reported: The number of participants with adverse events
Time Frame: Up to 24 hours
|
Up to 24 hours
|
Part A: To examine the safety and tolerability of TC-5214. The following assessments will be measured and reported: A change from baseline in laboratory assessments.
Time Frame: Up to 24 hours
|
Up to 24 hours
|
Part A: To examine the safety and tolerability of TC-5214. The following assessments will be measured and reported: A change from baseline in vital signs.
Time Frame: Up to 24 hours
|
Up to 24 hours
|
Part A: To examine the safety and tolerability of TC-5214. The following assessments will be measured and reported: A change from baseline in electrocardiogram (ECG).
Time Frame: Up to 24 hours
|
Up to 24 hours
|
Part A: To examine the safety and tolerability of TC-5214. The following assessments will be measured and reported: A change from baseline in physical examination.
Time Frame: Up to 24 hours
|
Up to 24 hours
|
Part B: The maximum mean change in time-matched ECG interval, measured from the onset of the QRS complex to the T point, using the best heart rate correction method (QTc).
Time Frame: Up to 24 hours
|
Up to 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Part A: TC-5214 Plasma and urine pharmacokinetic variable to be measured: including, C max, time to C max, Area Under Curve (AUC) (0-t), terminal half life, cumulative amount of drug excreted unchanged into urine from zero to time and renal clearance
Time Frame: Up to 72 Hours
|
Up to 72 Hours
|
Part B: A change in the maximum of the mean change in time-matched ECG interval, measured from the onset of the QRS complex
Time Frame: Up to 24 Hours
|
Up to 24 Hours
|
Part B: Assay sensitivity by measuring the effect of moxifloxacin 400 mg on QTc compared to placebo
Time Frame: Up to 24 hours
|
Up to 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hans A Eriksson, MD, PhD, MBA, AstraZeneca
- Study Chair: Brendan Smyth, MD, AstraZeneca
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
April 28, 2011
First Submitted That Met QC Criteria
May 23, 2011
First Posted (Estimate)
May 25, 2011
Study Record Updates
Last Update Posted (Estimate)
December 12, 2012
Last Update Submitted That Met QC Criteria
December 11, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral, Combined
- Contraceptives, Oral
- Contraceptive Agents, Female
- Moxifloxacin
- Norgestimate, ethinyl estradiol drug combination
Other Study ID Numbers
- D4130C00009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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