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

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. Identifier: NCT01145768
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : December 8, 2010
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Brief Summary:
To investigate the safety and tolerability of TC-5214 following oral administration of single and multiple ascending doses compared to placebo.

Condition or disease Intervention/treatment Phase
Healthy Drug: TC-5214 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : June 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Arm Intervention/treatment
Experimental: 1
Each cohort will have 9 volunteers that will receive TC-5214
Drug: TC-5214
4 mg tablet, oral, BID, group 1

Drug: TC-5214
TBD tablet, oral, BID, groups 2-6

Placebo Comparator: 2
Each cohort will have 3 volunteers that will receive placebo
Drug: Placebo

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

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

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

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 identifier (NCT number): NCT01145768

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United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
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Principal Investigator: David Mathews, MD Quintiles, Inc.
Study Chair: Donna Holloway Quintiles, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: MSD, AstraZeneca Identifier: NCT01145768     History of Changes
Other Study ID Numbers: D4130C00006
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: December 8, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
parallel-group study