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

NCT00868361 | Terminated Phase 1

• 1 other identifier: TAL-MB-100
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Mass Balance; Talampanel; Pharmacokinetics; Metabolism; Metabolites; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• To determine the mass balance of [14C]-talampanel. To characterize the metabolism of [14C] talampanel in plasma, feces, and urine. To assess the pharmacokinetics (PK) of total radioactivity, talampanel, and N-acetyl talampanel.

  6-9 days

Secondary Outcomes (1)

• To explore the effect of N-acetyltransferase 2 (NAT2) genotype on the PK and metabolism of [14C] talampanel. To further assess the safety and tolerability of talampanel.

  6-9 days

Study Arms (1)

Slow and rapid N-acetyl transferase genotypes

EXPERIMENTAL

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

Interventions

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

50 mg capsule single dose

Also known as: TV-7600

Slow and rapid N-acetyl transferase genotypes

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead
• Covance: collaborator

Study Sites (1)

Covance Clinical Pharmacology Inc.

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

talampanel

Study Officials

• Nicholas M Siebers, MD

  Covance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 24, 2009
• First Posted: March 25, 2009
• Study Start: May 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: September 16, 2009

Record last verified: 2009-09

Locations

US (1)