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

Purpose

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

Condition	Intervention	Phase
Healthy Subjects	Drug: TC-5214	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

TC-5214 area under the plasma concentration time curve will be measured. [ Time Frame: 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 ] [ Designated as safety issue: No ]
TC-5214 maximum plasma concentration will be measured [ Time Frame: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The number of participants with adverse events [ Time Frame: During day - 1, day 1, 2, 3 and 4 of treatment period ] [ Designated as safety issue: Yes ]
A change from baseline in laboratory assessments [ Time Frame: During day - 1 and day 3 of visits 2 and 3 of treatment period ] [ Designated as safety issue: Yes ]
A change from baseline in vital signs [ Time Frame: During day - 1, day 1, 2, 3 and 4 of treatment period ] [ Designated as safety issue: Yes ]
A change from baseline in physical examination [ Time Frame: During day -1 ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
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 [ Time Frame: PK samples collected at pre dose, 0 - 12, 12 - 24, 24 to 48 hours post dose ] [ Designated as safety issue: No ]

Enrollment:	18
Study Start Date:	November 2011
Study Completion Date:	January 2012
Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01458899

Locations

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

Sponsors and Collaborators

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

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01458899 History of Changes
Other Study ID Numbers:	D4130C00025
Study First Received:	October 17, 2011
Last Updated:	January 10, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Phase 1
healthy male
nonpregnant female
volunteers

pharmacokinetics
TC 5214
The effect of food on the pharmacokinetics of TC-5214

ClinicalTrials.gov processed this record on May 23, 2013