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

This study has been terminated.
(Poor recruitment of fast and slow acetylators)
Sponsor:
Collaborator:
Covance
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00868361
First received: March 24, 2009
Last updated: September 15, 2009
Last verified: September 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: Talampanel (non-radiolabeled), [14C] Talampanel
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Open-label Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C]-Talampanel Following Oral Administration to Healthy Male

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 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. [ Time Frame: 6-9 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 6-9 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: May 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Slow and rapid N-acetyl transferase genotypes
N/A
 Drug: Talampanel (non-radiolabeled), [14C] Talampanel
50 mg capsule single dose
Other Name: TV-7600

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00868361

Locations
United States, Wisconsin
Covance Clinical Pharmacology Inc.
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Teva Pharmaceutical Industries
Covance
Investigators
Principal Investigator: Nicholas M Siebers, MD Covance Clinical Research Unit Inc.
  More Information

No publications provided

Responsible Party: Siyu Liu, M.D., Ph.D., Vice President, Innovative Research and Development and Head of Global Clinical Operations
ClinicalTrials.gov Identifier: NCT00868361     History of Changes
Other Study ID Numbers: TAL-MB-100
Study First Received: March 24, 2009
Last Updated: September 15, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Mass Balance
Talampanel
Pharmacokinetics
 Metabolism
Metabolites
Healthy Volunteers

ClinicalTrials.gov processed this record on June 18, 2013