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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-01-31

Brief Summary

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

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Detailed Description

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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

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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A - first fed then fasted treatment

TC-5214

Group Type EXPERIMENTAL

TC-5214

Intervention Type DRUG

Oral tablets, single 4mg dose

B - first fasted then fed treatment

TC-5214

Group Type EXPERIMENTAL

TC-5214

Intervention Type DRUG

Oral tablets, single 4mg dose

Interventions

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TC-5214

Oral tablets, single 4mg dose

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes