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

Teva Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Moxifloxacin

Drug: Talampanel

Drug: Placebo

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT00964730

R09-0539

TAL-TQT-101

Details and patient eligibility

About

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

Enrollment

135 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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