Skip to main content
OpenTrials
Completed

NCT Number: NCT01458899

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Subjects

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Overland Park, Kansas, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TC-5214

Drug

Oral tablets, single 4mg dose

Primary outcomes

  1. 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

  2. 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 outcomes

  1. The number of participants with adverse events

    Time frame: During day - 1, day 1, 2, 3 and 4 of treatment period

  2. A change from baseline in laboratory assessments

    Time frame: During day - 1 and day 3 of visits 2 and 3 of treatment period

  3. A change from baseline in vital signs

    Time frame: During day - 1, day 1, 2, 3 and 4 of treatment period

  4. A change from baseline in physical examination

    Time frame: During day -1

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: TC-5214

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 25, 2011
Registry last updated
Jan 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.