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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: TC-5214

Study type: Interventional

Funder types: Industry

Identifiers

NCT01175564

D4131C00002

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

48 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

Each cohort will have 9 volunteers that will receive TC-5214

Treatment:

Drug: TC-5214

Placebo

Placebo Comparator group

Description:

Each cohort will have 3 volunteers that will receive placebo

Treatment:

Drug: Placebo