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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01392820
First received: July 11, 2011
Last updated: November 14, 2011
Last verified: November 2011
History of Changes
  Purpose

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


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, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. [ Time Frame: During the whole study period, ca. 50 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • characterise the PK of TC-5214 in plasma and urine during single and multiple ascending oral doses to Japanese healthy elderly volunteers. [ Time Frame: PK samplings are taken at defined timepoints during residential periods, 4 days for SAD part and/or 9 days for MAD part. ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: July 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TC-5214 Drug: TC-5214
Tablet, Oral, twice daily
Placebo Comparator: Placebo Drug: Placebo
Tablet, Oral, twice daily

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01392820

Locations
Japan
Research Site
Fukuoka, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Hans Eriksson, MD AstraZeneca
Principal Investigator: Shunji Matsuki, MD Kyushu Clinical Pharmacology Research Clinic
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01392820     History of Changes
Other Study ID Numbers: D4131C00003
Study First Received: July 11, 2011
Last Updated: November 14, 2011
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
Phase I
Japan
Elderly
 PK
SAD
MAD

ClinicalTrials.gov processed this record on May 16, 2013