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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: TC-5214

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A - first fed then fasted treatment; TC-5214	Drug: TC-5214; Oral tablets, single 4mg dose
Experimental: B - first fasted then fed treatment; TC-5214	Drug: TC-5214; Oral tablets, single 4mg dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Chair: Hans A Eriksson, MD, AstraZeneca Kvambergagatan 12, 15185, Sodertalje, Sweden; Principal Investigator: David Mathews, MD, Quintiles, Inc. Overland Park US; Study Director: Brendan Smyth, MD, AstraZeneca 180 Concord Pike Wilmington, DE 19850-5437

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: October 17, 2011
• First Submitted That Met QC Criteria: October 24, 2011
• First Posted (Estimate): October 25, 2011

Study Record Updates

• Last Update Posted (Estimate): January 11, 2012
• Last Update Submitted That Met QC Criteria: January 10, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: pharmacokinetics; volunteers; Phase 1; healthy male; nonpregnant female; TC 5214; The effect of food on the pharmacokinetics of TC-5214
• Other Study ID Numbers: D4130C00025