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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01458899
First Posted: October 25, 2011
Last Update Posted: January 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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
Intervention Model: Crossover Assignment
Masking: None (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 ]
  • 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 ]

Secondary Outcome Measures:
  • The number of participants with adverse events [ Time Frame: During day - 1, day 1, 2, 3 and 4 of treatment period ]
  • A change from baseline in laboratory assessments [ Time Frame: During day - 1 and day 3 of visits 2 and 3 of treatment period ]
  • A change from baseline in vital signs [ Time Frame: During day - 1, day 1, 2, 3 and 4 of treatment period ]
  • A change from baseline in physical examination [ Time Frame: 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 [ 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 ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01458899     History of Changes
Other Study ID Numbers: D4130C00025
First Submitted: October 17, 2011
First Posted: October 25, 2011
Last Update Posted: January 11, 2012
Last Verified: January 2012

Keywords provided by AstraZeneca:
Phase 1
healthy male
nonpregnant female
volunteers
pharmacokinetics
TC 5214
The effect of food on the pharmacokinetics of TC-5214