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

NCT00964730 | Completed Phase 1

• 2 other identifiers: TAL-TQT-101R09-0539
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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

Keywords

Thorough QT Study; Talampanel; Cardiac Repolarizatiom; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• To determine the effects of Talampanel on cardiac repolarization after multiple therapeutic doses administered over 10 days

  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

  12 days

Study Arms (3)

Talampanel

EXPERIMENTAL

Drug: Talampanel

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Moxifloxacin

OTHER

Drug: Moxifloxacin

Interventions

Talampanel DRUG

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

Also known as: TV-7600, GYKI 53773

Talampanel

Moxifloxacin DRUG

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

Also known as: Avelox

Moxifloxacin

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead
• Cetero Research, San Antonio: collaborator

Study Sites (1)

Cetero Research - Fargo

Fargo, North Dakota, 58104, United States

Location

MeSH Terms

Interventions

talampanel; Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Craig R Sprenger, MD

  Cetero Research - Fargo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 21, 2009
• First Posted: August 25, 2009
• Study Start: October 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: February 1, 2010
• Last Updated: April 7, 2010

Record last verified: 2010-04

Locations

US (1)