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

Completed · Phase 1

Conditions studied: Healthy Subjects

In brief

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

Key facts

Study ID

NCT01458899

Run by

AstraZeneca

People needed

18

Starts

2011-11-01

Expected to finish

2012-01-01

Last updated by the study team

2012-01-11

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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