A Study to Investigate the Absorption, Metabolism and Excretion of Talampanel

NCT ID: NCT00868361

Last Updated: 2009-09-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2009-09-30

Brief Summary

The purpose of this study is to characterize the chemical breakdown and excretion of talampanel and its break down products in plasma, feces, and urine of healthy human volunteers.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Slow and rapid N-acetyl transferase genotypes

Group Type: EXPERIMENTAL

Talampanel (non-radiolabeled), [14C] Talampanel

Intervention Type: DRUG

50 mg capsule single dose

Interventions

Talampanel (non-radiolabeled), [14C] Talampanel

50 mg capsule single dose

Intervention Type: DRUG

Other Intervention Names

TV-7600

Eligibility Criteria

Inclusion Criteria

• Males, between 18 and 55 years of age, inclusive
• Body Mass Index range 18.0 to 30.0 kg/m2, inclusive
• Have NAT2 slow or rapid acetylator genotype
• In good health as determined by the investigator
• Negative test for selected drugs of abuse at screening
• Negative screens for Hepatitis B, Hepatitis C and HIV
• Sterile or agrees to use an approved method of contraception from Check-in until 45 days following Clinic Discharge
• Able to comprehend and willing to sign an Informed Consent Form
• Have 1 to 2 bowel movements per day

Exclusion Criteria

• Significant history or clinical manifestation of any significant metabolic, allergic, skin, liver, kidney, blood, heart or blood vessel, digestive system, brain or psychiatric disorder
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
• History of stomach or intestinal surgery or resection
• History or presence of an abnormal ECG,
• History of clinically significant alcohol or drug use within 1 year prior to Check-in
• Participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to Check-in
• Exposure to significant radiation within 12 months prior to Check-in -Use of any tobacco- or nicotine-containing within 6 months prior to Check- in
• Use of any drugs which may interact with the study drug within 30 days prior to Check-in
• Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days prior to Check-in
• Use of any prescription medications/products within 14 days prior to Check in
• Use of any over-the-counter, non-prescription drugs within 7 days prior to Check-in
• Use of grapefruit or grapefruit-containing foods or beverages within 7 days prior to Check-in
• Use of alcohol- or caffeine-containing foods or beverages within 72 hours prior to Check-in
• Donation of blood from 30 days prior to Screening through Study Completion, inclusive, or of plasma from 2 weeks prior to Screening through Study Completion
• Receipt of blood products within 2 months prior to Check-in
• Any acute or chronic condition that would limit the subject's ability to complete and/or participate in this clinical study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Covance

INDUSTRY

Sponsor Role: collaborator

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Vice President, Innovative Research and Development and Head of Global Clinical Operations

Principal Investigators

Nicholas M Siebers, MD

Role: PRINCIPAL_INVESTIGATOR

Covance

Locations

Covance Clinical Pharmacology Inc.

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

TAL-MB-100

Identifier Type: -

Identifier Source: org_study_id