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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01392820 |
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Date of registration:
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11/07/2011 |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
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Date of first enrolment:
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July 2011 |
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Target sample size:
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48 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01392820 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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Countries of recruitment
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Japan
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Contacts
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Name:
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Hans Eriksson, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca |
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Name:
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Shunji Matsuki, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kyushu Clinical Pharmacology Research Clinic |
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Key inclusion & exclusion criteria
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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.
Age minimum:
65 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: Placebo
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Drug: TC-5214
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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.]
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Secondary ID(s)
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D4131C00003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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