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

Healthy Clinical Trial

Official title:

A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of TC-5214 in Japanese Healthy Elderly Male and Female Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01392820
• Other study ID #: D4131C00003
• Status: Completed
• Phase: Phase 1
• First received: July 11, 2011
• Last updated: November 14, 2011
• Start date: July 2011
• Est. completion date: October 2011

Study information

• Verified date: November 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• TC-5214
Tablet, Oral, twice daily
• Placebo
Tablet, Oral, twice daily

Locations

Country	Name	City	State
Japan	Research Site	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess the safety and tolerability during single and multiple ascending oral doses by assessment of AEs, brief neurological examinations, vital signs, eye symptoms question, physical examinations, laboratory parameters, and ECGs, and C-SSRS.		During the whole study period, ca. 50 days	Yes
Secondary	characterise the PK of TC-5214 in plasma and urine during single and multiple ascending oral doses to Japanese healthy elderly volunteers.		PK samplings are taken at defined timepoints during residential periods, 4 days for SAD part and/or 9 days for MAD part.	No