A Study to Investigate the Absorption, Metabolism and Excretion of Talampanel - Full Text View

Sponsors and Collaborators:	Teva Pharmaceutical Industries Covance
Information provided by:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00868361

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 I

MedlinePlus related topics: Urine and Urination

Drug Information available for: GYKI 53773

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
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

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
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Slow and rapid N-acetyl transferase genotypes: Experimental N/A	Drug: Talampanel (non-radiolabeled), [14C] Talampanel 50 mg capsule single dose

Detailed Description:

This study will be an open-label, non-randomized, absorption, metabolism, and excretion study of a single 50 mg talampanel dose administered in a capsule dosage form containing [14C]-talampanel to up to 10 healthy male subjects, equal numbers of subjects with NAT2 slow and rapid acetylator genotypes.

Plasma, urine, and feces will be collected at predefined time points. Potential subjects will be screened to assess their eligibility to enter the study prior to Check-in. A Preliminary Screening will be performed to identify subjects with NAT2 slow and rapid acetylator genotypes.

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

Contacts

Contact: Nicholas M. Siebers, MD	608-442-2712	nicholas.siebers@covance.com
Contact: Cindy Davis, R.N.	608-443-1490	cynthia.davis@covance.com

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

Keywords provided by Teva Pharmaceutical Industries:

Mass Balance
Talampanel
Pharmacokinetics

Metabolism
Metabolites
Healthy Volunteers

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009