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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: TC-5214

• Registration Number: NCT01458899
• Lead Sponsor: AstraZeneca

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

Study Timeline

• Study First Submitted: 2011-10-17
• Study First Submitted QC: 2011-10-24
• Study First Posted: 2011-10-25
• Study Start: 2011-11
• Status Verified: 2012-01
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Last Update Submitted: 2012-01-10
• Last Update Posted: 2012-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A - first fed then fasted treatment	TC-5214	TC-5214
B - first fasted then fed treatment	TC-5214	TC-5214

Primary Outcome Measures

Name	Time	Method
TC-5214 area under the plasma concentration time curve will be measured.	Pre dose, 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 7, 12, 24, 36, 48 and 72 hours post dose
TC-5214 maximum plasma concentration will be measured	Pre dose, 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 7, 12, 24, 36, 48 and 72 hours post dose

Secondary Outcome Measures

Name	Time	Method
Description of urine pharmacokinetics (PK) of TC-5214 in terms of the cumulative amount of drug excreted unchanged into urine from zero to time and renal clearance	PK samples collected at pre dose, 0 - 12, 12 - 24, 24 to 48 hours post dose
The number of participants with adverse events	During day - 1, day 1, 2, 3 and 4 of treatment period
A change from baseline in laboratory assessments	During day - 1 and day 3 of visits 2 and 3 of treatment period
A change from baseline in vital signs	During day - 1, day 1, 2, 3 and 4 of treatment period
A change from baseline in physical examination	During day -1
Description of the pharmacokinetics (PK) of TC-5214 in terms of area under the curve over the time (AUC) and maximum concentration (Cmax) and terminal half-life	PK samles collected at pre dose, 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 7, 12, 24, 36, 48 and 72 hours post dose

Trial Locations

Locations (1)

Research Site; 🇺🇸 Overland Park, Kansas, United States