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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01175564
First received: July 23, 2010
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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. ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01175564

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01175564     History of Changes
Other Study ID Numbers: D4131C00002
Study First Received: July 23, 2010
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration
Japan: Ministry of Health, Labor and Welfare

Keywords provided by AstraZeneca:
TC-5214
safety
pharmacokinetics
single dose
 repeated dose
Japanese
healthy subjects

ClinicalTrials.gov processed this record on June 18, 2013