A Study of Single and Multiple Ascending Doses of TC-5214 in Japanese Healthy Elderly Male and Female Volunteers

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: TC-5214; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01392820

D4131C00003

Details and patient eligibility

About

The purpose of this study is to assess safety, tolerability and pharmacokinetics of TC-5214 in elderly healthy Japanese volunteers.

Enrollment: 48 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Japanese healthy elderly male and female ≥65 years old.
• Have a BMI of ≥18 and ≤27 kg/m2 and weigh ≥ 45 kg.
• Be able to understand and comply with the requirements of the study as judged by the investigator(s).

Exclusion criteria

• History of any clinically significant medical or neurologic disease or disorder.
• History of gastrointestinal surgery or unintentional rapid weight loss.
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the study drug.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

TC-5214

Experimental group

Treatment:

Drug: TC-5214

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo