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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: |
NCT01427387 |
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Date of registration:
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31/08/2011 |
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Primary sponsor: |
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Public title:
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A Study to Evaluate Safety of Multiple Dose of ASP0456 in Healthy Subjects
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Scientific title:
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Phase I Study of ASP0456 - A Double-blind, Placebo-controlled, Multiple Ascending Dose Study / Investigational Study for Dose Timing Selection in Non Elderly Healthy Subjects- |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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44 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01427387 |
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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: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
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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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Use Cental Contact |
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Address:
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Telephone:
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Email:
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Affiliation:
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Astellas Pharma Inc |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy, as judged by the investigator/subinvestigator based on the results of
physical examination and all tests obtained
- Body weight (at screening);
- female =40.0 kg,<70.0 kg
- male =50.0 kg,<80.0 kg
- BMI(at screening): =17.6,<26.4
Exclusion Criteria:
- Received any investigational drugs in other clinical or post-marketing studies within
120 days before the study
- Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days,
or blood components within 14 days before the study
- Received medication within 10 days before dose is administered or is scheduled to
receive medication
- History of drug allergies
- Upper (e.g. nausea, vomiting, stomachache) and lower (e.g. abdominal pain)
gastrointestinal disease within 7 days before the study
- Concurrent or previous hepatic disease
- Concurrent or previous heart disease
- Concurrent or previous renal disease
Age minimum:
20 Years
Age maximum:
44 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy
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Pharmacokinetics of ASP0456
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Intervention(s)
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Drug: ASP0456
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Drug: Placebo
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Primary Outcome(s)
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Pharmacokinetics (such as Cmax, AUC and t1/2 etc.) of ASP0456 assessed by its plasma concentration change
[Time Frame: For 48 hours after dosing]
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Secondary Outcome(s)
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Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and labo tests
[Time Frame: For 48 hours after dosing]
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Secondary ID(s)
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0456-CL-0012
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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