- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01279915
A Safety and Pharmacokinetics Study of ASP0456 in Healthy Subjects
January 18, 2011 updated by: Astellas Pharma Inc
Phase I Study of ASP0456 - A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study in Non-elderly Healthy Male Subjects
A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending dose of ASP0456 in non-elderly healthy subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kantou, Japan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 44 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy, as judged by the investigator/subinvestigator based on the results of physical examination and all tests obtained
- Body weight (at screening); ≥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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ASP group
ASP0456 receiving group
|
oral
Other Names:
|
Placebo Comparator: Placebo group
Placebo treatment
|
oral
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics of ASP0456 assessed by its plasma concentration change
Time Frame: For 48 hours after dosing
|
For 48 hours after dosing
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and labo tests
Time Frame: For 48 hours after dosing
|
For 48 hours after dosing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
January 18, 2011
First Submitted That Met QC Criteria
January 18, 2011
First Posted (Estimate)
January 20, 2011
Study Record Updates
Last Update Posted (Estimate)
January 20, 2011
Last Update Submitted That Met QC Criteria
January 18, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0456-CL-0011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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