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Completed

NCT Number: NCT01145768

To Investigate the Safety and Tolerability of TC-5214 Following Oral Administration of Multiple Doses for up to 8 Days

To investigate the safety and tolerability of TC-5214 following oral administration of single and multiple ascending doses compared to placebo.

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Key information

Conditions

Healthy

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

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male and nonpregnant, nonlactating female, with suitable veins for cannulation or repeated venipuncture
  • Contraceptive use from the first dose of investigational product until12 weeks after their last dose
  • Body mass index (BMI) between 19 and 32 kg/m2 and weigh at least 50 kg

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 of
  • History of gastrointestinal surgery (except for cholecystectomy and appendectomy) or unintentional rapid weight loss
  • Volunteers with a history of suicide attempts in the past year and/or seen by the Investigator as having a significant history of risk of suicide or homicide, or considered at risk for suicide or homicide during the study

Treatment and study plan

TC-5214

Drug

4 mg tablet, oral, BID, group 1

Placebo

Drug

Primary outcomes

  1. safety and tolerability assessed by incidence and severity of AE's, abnormalities in vital sign assessments, ECG's, telemetry, clinical lab assessments, physical exams, neurological exams, suicidality evaluations, visual acuity tests and digital ECGs

    Time frame: Collected prior to treatment, during treatment and for 7-10 days following discharge. Volunteers will be monitored througout the study for adverse events.

Secondary outcomes

  1. To characterize the pharmacokinetics of TC-5214 in blood and urine after single and repeated oral doses by collecting blood and urine samples to measure drug concentration levels

    Time frame: Blood sampling, every in house day; urine collection ;Days -1 through Day 6, Days 8 through 11.

  2. To assess the effect of food on the pharmacokinetics of TC-5214 following oral administration by collecting blood and urine samples to measure drug concentration levels.

    Time frame: Samples taken during the residential period at defined timepoints pre-dose and post-dose

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase 1, Single Center, Double-blind, Randomized, Placebo- Controlled, Parallel-group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral TC-5214 (S-Mecamylamine) After Administration of Single and Multiple Ascending Doses for up to 8 Days in Healthy Male and Female Subjects

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 17, 2010
Registry last updated
Dec 8, 2010

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.

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