Status:
COMPLETED
Study in Healthy Subjects to Measure the Effects of Food on the Pharmacokinetics of TC-5214
Lead Sponsor:
AstraZeneca
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
(Food versus no food) crossover study to measure the effects of food on pharmacokinetics of TC-5214 (S-Mecamylamine) in healthy Subjects.
Detailed 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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01458899
Start Date
November 1 2011
End Date
January 1 2012
Last Update
January 11 2012
Active Locations (1)
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1
Research Site
Overland Park, Kansas, United States