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

Teva Pharmaceuticals

Status and phase

Terminated

Phase 1

Conditions

Healthy

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00868361

TAL-MB-100

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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