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To Investigate Safety, Tolerability and Pharmacokinetics of TC-5214 in Healthy Male Japanese Subjects

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: July 23, 2010
Last updated: February 5, 2013
Last verified: February 2013
The purpose of this study is to assess safety, tolerability and pharmacokinetics after a single and repeated oral doses of TC-5214 (S-mecamylamine) in healthy male Japanese subjects.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase I, Single Centre, Randomised, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of a Single Dose and Multiple Doses of TC-5214 (S-Mecamylamine) in Healthy Male Japanese Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Safety by assessment of adverse events, brief neurological examinations, visual acuity test, vital signs, physical examinations, laboratory parameters, and electrocardiograms (ECGs), and Columbia Suicide Severity Rating Scale (C-SSRS). [ Time Frame: Collected prior to treatment, during treatment and 7-10 days following discharge. Volunteers will be monitored througout the study for adverse events. ]

Secondary Outcome Measures:
  • Under Single Dosing conditions: Cmax, tmax, λz, t½λz, AUC(0-12), AUC(0-t), AUC, AUMC, MRT, % AUC extrapolated, CL/F, Vss/F, Ae fraction, Fe, (% of dose) Renal CLR. [ Time Frame: Blood samples are taken repeatedly for 24 hours after dosing for 24 hours on Day 1 for SAD ]
  • Under Multiple Dosing Conditions: Css, max, Cmin, Cmax (tss,max), λz, t½λz, AUCss, AUC(0-t), AUC, AUMC, MRT, % AUC extrapolated, CL/F, Vss/F, Ae, Fe % of dose,Renal CLR, Rac(Cmax), Rac(AUC), Rac(Cmin)), LI, % fluctuation, time to reach the steady state [ Time Frame: Blood samples are taken repeatedly for 24 hours after dosing for 24 hours on Day 1 for SAD and Day 6 (last dose) for MAD. ]

Enrollment: 48
Study Start Date: July 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
Each cohort will have 9 volunteers that will receive TC-5214
Drug: TC-5214
Four increasing doses levels of a single dose and two increasing dose levels of 6 days repeated dose of TC-5214 tablet
Placebo Comparator: Placebo
Each cohort will have 3 volunteers that will receive placebo
Drug: Placebo
Placebo tablet, single dose and 6 days repeated dose


Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Japanese Healthy male ≥20 and ≤55 years old inclusive with suitable veins for cannulation or repeated venipuncture
  • Have a body mass index (BMI) of ≥18 and ≤27 kg/m2 and weigh at least 50 kg

Exclusion Criteria:

  • History of any clinically significant medical or neurologic disease or disorder which, in the opinion of the investigator and sponsor, may either put the subject at risk because of participation in the study, or influence the results of the subject's
  • History of psychiatric disorders
  • Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01175564

Sponsors and Collaborators
Study Director: Hans Eriksson AstraZeneca R&D Sodertalje, SE-151 85 Sodertalje, Sweden
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT01175564     History of Changes
Other Study ID Numbers: D4131C00002
Study First Received: July 23, 2010
Last Updated: February 5, 2013

Keywords provided by AstraZeneca:
single dose
repeated dose
healthy subjects processed this record on September 21, 2017