Status:

COMPLETED

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

Lead Sponsor:

AstraZeneca

Conditions:

Healthy

Eligibility:

MALE

20-55 years

Phase:

PHASE1

Brief Summary

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.

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

July 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2010

Estimated Enrollment :

48 Patients enrolled

Trial Details

Trial ID

NCT01175564

Start Date

July 1 2010

End Date

September 1 2010

Last Update

February 6 2013

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