Study in Healthy Subjects to Measure the Effects of Food on the Pharmacokinetics of TC-5214

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Treatments

Drug: TC-5214

Study type

Interventional

Funder types

Industry

Identifiers

NCT01458899

D4130C00025

Details and patient eligibility

About

(Food versus no food) crossover study to measure the effects of food on pharmacokinetics of TC-5214 (S-Mecamylamine) in healthy Subjects.

Full description

Phase I, Open-label, Randomized, Single-dose, Two treatment (Fed Versus Fasted) Crossover Study to Assess the Effects of Food on the Pharmacokinetics of TC-5214 (S-Mecamylamine) in Healthy Subjects

Enrollment

18 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Provision of signed, written, and dated informed consent prior to any study specific procedures.
Healthy male and nonpregnant, nonlactating female 18 to 55 years, inclusive, with suitable veins for cannulation or repeated venipuncture.
Have a body mass index (BMI) between 19 and 32 kg/m2 and weigh at least 50 kg
Be willing to eat the high-calorie, high-fat breakfast or fast accordingly
Be able to understand and comply with the requirements of the study as judged by the Investigator

Exclusion criteria

History of any clinically significant medical, neurologic, or psychiatric disease or disorder which, in the opinion of the Investigator and Sponsor, may either put the volunteer at risk because of participation in the study, or influence the results
History of gastrointestinal surgery (except for appendectomy) or unintentional rapid weight loss
History of seizure activity, including febrile seizures
Past diagnosis of more than 1 episode of major depression
History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs