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Healthy MalePhase 1NCT01359618

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

A Phase 1 study testing TC-5214 and Moxifloxacin in people with Healthy Male, run by AstraZeneca at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Male
What is being tested?
TC-5214 and Moxifloxacin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
1 siteUnited Kingdom
Study dates
Jun 2011to Apr 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Research Site

    London

Other trials in United Kingdom

About this study

Official title: 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.

Conditions
Healthy Male
Being tested
TC-5214, Placebo comparator, Moxifloxacin, Moxifloxacin placebo comparator
Keywords
Phase I, Safety, tolerability, healthy, major depressive disorder, thorough QT, maximum tolerated dose, elimination, heart electrical signal
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TC-5214Drug

    Single dose, oral tablets

  • Placebo comparatorOther

    Single dose, oral tablets

  • MoxifloxacinDrug

    Also called Avelox®

    Single dose, oral encapsulated tablet

  • Moxifloxacin placebo comparatorOther

    Single dose, oral encapsulated tablet

Study groups in NCT01359618
Study groupRoleWhat they receive
Part A 1ExperimentalTC-5214
Receives: Drug: TC-5214
Part A 2ExperimentalTC-5214 placebo
Receives: Other: Placebo comparator
Part B 1ExperimentalTC-5214 8 mg + moxifloxacin placebo
Receives: Drug: TC-5214; Other: Moxifloxacin placebo comparator
Part B 2ExperimentalTC-5214 supratherapeutic dose + moxifloxacin placebo
Receives: Drug: TC-5214; Other: Moxifloxacin placebo comparator
Part B 3Active comparatorTC-5214 placebo + moxifloxacin 400 mg
Receives: Other: Placebo comparator; Drug: Moxifloxacin
Part B 4Placebo comparatorTC-5214 placebo + moxifloxacin placebo
Receives: Other: Placebo comparator; Other: Moxifloxacin placebo comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 24 hours

  2. 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.

    Measured: Up to 24 hours

  3. 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.

    Measured: Up to 24 hours

  4. 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).

    Measured: Up to 24 hours

  5. 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.

    Measured: Up to 24 hours

  6. 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).

    Measured: Up to 24 hours

Secondary outcomes (3)

  1. 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

    Measured: Up to 72 Hours

  2. Part B: A change in the maximum of the mean change in time-matched ECG interval, measured from the onset of the QRS complex

    Measured: Up to 24 Hours

  3. Part B: Assay sensitivity by measuring the effect of moxifloxacin 400 mg on QTc compared to placebo

    Measured: Up to 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionApr 2012
  4. Study completionApr 2012

Why it stopped: Sponsor decision to terminate

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01359618
Sponsor's protocol ID
D4130C00009
Status last verified
Dec 2012
First submitted
28 Apr 2011
Last updated
12 Dec 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TC-5214 and Moxifloxacin in people with Healthy Male, run by AstraZeneca at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor decision to terminate). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01359618.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2012.

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