HealthyPhase 1NCT00964730
A Phase 1 Study to Investigate the Effects of Talampanel on the Heart Rhythm
A Phase 1 study testing Talampanel and Moxifloxacin in people with Healthy, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess whether multiple doses of Talampanel increase the QT interval when compared to placebo Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Talampanel and Moxifloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Feb 2010
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers aged 18 to 50 years of age inclusive.
- Body mass index: Between 18 and 30 kg/m2 and weight of at least 50 kg.
- Female volunteers must have either a negative pregnancy test and be willing to use birth control, be post-menopausal evidenced by lab test, or be surgically sterile.
- Volunteers must be able to understand the requirements of the study and must be willing to comply with the requirements of the study and provide their written informed consents to participate in the study prior to the conduct of study procedures.
Who cannot join
- Male and female volunteers with a resting QT interval of < 320 msec or > 450 msec (males) or > 470 msec (females
- Volunteers with ECG abnormalities that may interfere with the accurate assessment of the QT interval
- Volunteers with known cardiovascular disorders, including coronary artery disease, valvular heart disease, cardiomyopathies, or ECG abnormalities suggestive of prior myocardial infarction, chamber enlargement or hypertrophy.
- Volunteers with known clinically significant arrhythmias or rhythm disturbances observed on ECG
- Volunteers who have a history of, or risk factors for, Torsades de Pointes (e.g. heart failure, abnormal serum electrolytes), including a history of family history of arrhythmia, sudden death, long QT syndrome, Brugada complex, or personal history of syncope.
- Volunteers who have a heart rate outside 40-90 beats per minute
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- Volunteers who have a blood pressure outside 90-140 mmHg systolic or 45-90 mmHg diastolic
- Volunteers with history of uncontrolled hypertension, impaired glucose tolerance, diabetes mellitus, kidney disease, edema, stroke or neurological disorder, rheumatological disorder, lung disease, heart disease, liver disease, or a history of any illness that pose additional risk to the volunteer
- Volunteers with a history of psychiatric disorders, including bipolar disorder, psychosis, previous episode(s) of major depression, history of suicidality or suicidal ideation.
- Volunteers who have history of surgeries or conditions that affect the way drugs are absorbed or distributed in the body such as intestinal surgery, stomach surgery.
- Volunteers with impaired liver function and elevated liver enzymes
- Volunteers with major trauma or surgery in the past 2 months, acute infection within 2 weeks, cancer within the last 5 years (excluding non-melanoma skin cancers), History of tuberculosis, abnormal lab tests
- Female volunteers who are lactating or intend to become pregnant during the study period.
- Volunteers with a known allergy or sensitivity to moxifloxacin or its derivatives, benzodiazepines, talampanel or its derivatives, or any contraindications to moxifloxacin, benzodiazepines, or talampanel.
- Volunteers with significant food or drug allergies
- Volunteers that have used an investigational drug (new chemical entity) 3 months prior to the start of the study,.who have consumed any medications (including over-the-counter medications, prescription medications, investigational drugs, vitamins, or herbal remedies) within 30 days prior to check-in (with the exception of hormonal contraceptives [females only] and occasional use of acetaminophen and ibuprofens, who have consumed amiodarone and chloroquine within 4 months prior to screening, who have consumed excessive amounts of alcohol or are unwilling to comply with the restricted use of alcohol during the study, who have consumed excessive amounts of coffee, tea, coke, or other caffeinated beverages within 2 weeks prior to check-in, who have consumed quinine (tonic water) within 7 days prior to study start, who have consumed grapefruit, grapefruit juice, or Seville orange juice within the 7 days prior to study start, who smoke, have smoked in the last 3 months, or are planning to start smoking during the study, tobacco users, subjects currently using nicotine products, or subjects with a positive urine cotinine test at study start
- Volunteers who are currently regular users (including recreational use) of any illicit drugs or who have a history of drug (including alcohol) abuse within 1 year of study start.
- Volunteers with positive urine test for drugs of abuse at screening or check-in.
- Volunteers who have donated or received any blood, plasma, or platelet transfusions in the 3 months prior to study start, or who have made donations on more than two occasions within the 12 months preceding the first dose administration, or who have planned donations during the study or during the 3 months following the study.
- Volunteers with a positive screening test for Hepatitis B, Hepatitis C or HIV
- Volunteers not willing to refrain from changing level of activity during the study and from jogging and strenuous exercise of all types while at the research unit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-Center, Double-Blind, Randomized, Placebo- and Positive- Controlled, Parallel Group, Thorough QT/QTc Study to Evaluate the Effect of Talampanel on Cardiac Repolarization in Healthy Male and Female Volunteers
The purpose of this study is to assess whether multiple doses of Talampanel increase the QT interval when compared to placebo
- Conditions
- Healthy
- Being tested
- Talampanel, Moxifloxacin, Placebo
- Keywords
- Thorough QT Study, Talampanel, Cardiac Repolarizatiom, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TalampanelDrug
Also called TV-7600, GYKI 53773
titrated to 50mg three times a day over 9 days and a single dose administered on Day 10
MoxifloxacinDrug
Also called Avelox
Placebo administered three times a day over 9 days and a single dose of moxifloxacin administered on Day 10
PlaceboDrug
administered three times a day over 9 days and a single dose administered on Day 10
| Study group | Role | What they receive |
|---|---|---|
| Talampanel | Experimental | Not described Receives: Drug: Talampanel |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Moxifloxacin | Other | Not described Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effects of Talampanel on cardiac repolarization after multiple therapeutic doses administered over 10 days
Measured: 12 days
Secondary outcomes (1)
Examine the PK profile of talampanel and its metabolite -Assess the PK/PD relationship of the time course of QT/QTc interval prolongation-Assess the safety and tolerability of multiple doses of talampanel in healthy volunteers
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startOct 2009
- Primary completionJan 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cetero Research, San Antonio
- Investigators
- Craig R Sprenger, MD, Principal investigator, Cetero Research - Fargo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964730
- Sponsor's protocol ID
- TAL-TQT-101
- Other IDs
- R09-0539
- Status last verified
- Apr 2010
- First submitted
- 21 Aug 2009
- Last updated
- 7 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Center, Double-Blind, Randomized, Placebo- and Positive- Controlled, Parallel Group, Thorough QT/QTc Study to Evaluate the Effect of Talampanel on Cardiac Repolarization in Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT00964730
- Acronym / sponsor ID
- TAL-TQT-101
- Conditions
- Healthy
- Keywords
- Thorough QT Study, Talampanel, Cardiac Repolarizatiom, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cetero Research, San Antonio
- Study start
- Oct 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 25 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess whether multiple doses of Talampanel increase the QT interval when compared to placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Talampanel | Experimental | Drug: Talampanel |
| Placebo | Placebo comparator | Drug: Placebo |
| Moxifloxacin | Other | Drug: Moxifloxacin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers aged 18 to 50 years of age inclusive.
- Body mass index: Between 18 and 30 kg/m2 and weight of at least 50 kg.
- Female volunteers must have either a negative pregnancy test and be willing to use birth control, be post-menopausal evidenced by lab test, or be surgically sterile.
- Volunteers must be able to understand the requirements of the study and must be willing to comply with the requirements of the study and provide their written informed consents to participate in the study prior to the conduct of study procedures.
Key exclusion criteria (21 listed)
- Male and female volunteers with a resting QT interval of < 320 msec or > 450 msec (males) or > 470 msec (females
- Volunteers with ECG abnormalities that may interfere with the accurate assessment of the QT interval
- Volunteers with known cardiovascular disorders, including coronary artery disease, valvular heart disease, cardiomyopathies, or ECG abnormalities suggestive of prior myocardial infarction, chamber enlargement or hypertrophy.
- Volunteers with known clinically significant arrhythmias or rhythm disturbances observed on ECG
- Volunteers who have a history of, or risk factors for, Torsades de Pointes (e.g. heart failure, abnormal serum electrolytes), including a history of family history of arrhythmia, sudden death, long QT syndrome, Brugada complex, or personal history of syncope.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TalampanelAlso: TV-7600, GYKI 53773titrated to 50mg three times a day over 9 days and a single dose administered on Day 10 | Drug | Talampanel |
| MoxifloxacinAlso: AveloxPlacebo administered three times a day over 9 days and a single dose of moxifloxacin administered on Day 10 | Drug | Moxifloxacin |
| Placeboadministered three times a day over 9 days and a single dose administered on Day 10 | Drug | Placebo |
Primary outcome
To determine the effects of Talampanel on cardiac repolarization after multiple therapeutic doses administered over 10 days
Time frame: 12 days
1 secondary outcome
Examine the PK profile of talampanel and its metabolite -Assess the PK/PD relationship of the time course of QT/QTc interval prolongation-Assess the safety and tolerability of multiple doses of talampanel in healthy volunteers
Time frame: 12 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig R Sprenger, MD principal investigator
Cetero Research - Fargo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Talampanel and Moxifloxacin in people with Healthy, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site in United States.
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 21 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: finished, as of the sponsor's last update on 7 Apr 2010. 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 States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the effects of Talampanel on cardiac repolarization after multiple therapeutic doses administered over 10 days (time frame: 12 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2010.