A Phase 1 Study to Investigate the Effects of Talampanel on the Heart Rhythm

NCT ID: NCT00964730

Last Updated: 2010-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-02-28

Brief Summary

The purpose of this study is to assess whether multiple doses of Talampanel increase the QT interval when compared to placebo

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Talampanel

Group Type: EXPERIMENTAL

Talampanel

Intervention Type: DRUG

titrated to 50mg three times a day over 9 days and a single dose administered on Day 10

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

administered three times a day over 9 days and a single dose administered on Day 10

Moxifloxacin

Group Type: OTHER

Moxifloxacin

Intervention Type: DRUG

Placebo administered three times a day over 9 days and a single dose of moxifloxacin administered on Day 10

Interventions

Talampanel

titrated to 50mg three times a day over 9 days and a single dose administered on Day 10

Intervention Type: DRUG

Moxifloxacin

Placebo administered three times a day over 9 days and a single dose of moxifloxacin administered on Day 10

Intervention Type: DRUG

Placebo

administered three times a day over 9 days and a single dose administered on Day 10

Intervention Type: DRUG

Other Intervention Names

TV-7600, GYKI 53773; Avelox

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cetero Research, San Antonio

NETWORK

Sponsor Role: collaborator

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Teva Neuroscience, Inc

Principal Investigators

Craig R Sprenger, MD

Role: PRINCIPAL_INVESTIGATOR

Cetero Research - Fargo

Locations

Cetero Research - Fargo

Fargo, North Dakota, United States

Countries

United States

Other Identifiers

R09-0539

Identifier Type: -

Identifier Source: secondary_id

TAL-TQT-101

Identifier Type: -

Identifier Source: org_study_id