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

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ClinicalTrials.gov Identifier: NCT01392820
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : November 15, 2011
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Healthy Drug: TC-5214 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011
Arms and Interventions
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Arm Intervention/treatment
Experimental: TC-5214 Drug: TC-5214
Tablet, Oral, twice daily
Placebo Comparator: Placebo Drug: Placebo
Tablet, Oral, twice daily


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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. ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01392820     History of Changes
Other Study ID Numbers: D4131C00003
First Posted: July 13, 2011    Key Record Dates
Last Update Posted: November 15, 2011
Last Verified: November 2011

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