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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1 Open-label Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C]-Talampanel Following Oral Administration to Healthy Male

Conditions
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Healthy

Intervention / Treatment
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* Drug: Talampanel (non-radiolabeled), [14C] Talampanel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Slow and rapid N-acetyl transferase genotypes<br> | Drug: Talampanel (non-radiolabeled), [14C] Talampanel<br>* 50 mg capsule single dose<br>* Other names: TV-7600;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mass Balance, Talampanel, Pharmacokinetics, Metabolism, Metabolites, Healthy Volunteers