Status:
COMPLETED
Multiple Oral Administration of ASP7991 to Non-elderly Male Subjects
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Healthy
Pharmacokinetics of ASP7991
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after multiple oral administrations to non-elderly subjects.
Detailed Description
In each step (lowest dose, middle dose, highest dose), subjects are randomly assigned in a double blinded manner to receive either ASP7991 (n=9) or Placebo (n=3) and are administered repeatedly. Once ...
Eligibility Criteria
Inclusion
- Healthy, as judged by the investigator/sub investigator based on the results of physical examination obtained before study drug administration
- Body weight: ≥50.0 kg, \<80.0 kg
- BMI: ≥17.6, \<26.4
- Serum corrected calcium concentration: ≥9.0mg/dL, \<10.4 mg/dL
Exclusion
- Received any investigational drugs in other clinical or post-marketing studies within 120 days before screening
- Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before screening
- Received medication (including marketed drug) within 7 days before hospitalization, vitamin preparation including vitamin D and supplement including calcium or is scheduled to receive medication
- A deviation from normal criteria range of 12-lead ECG (QT evaluation)
- A deviation from the normal range in clinical laboratory tests
- Highly sensitive cardiac troponin T (at screening): ≥0.014 ng/mL
- History of drug allergies
- Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before admission
- Concurrent or previous hepatic disease (e.g., viral hepatitis, drug-induced liver injury)
- Concurrent or previous endocrine disorders (e.g., hyperthyroidism, aberration in growth hormone)
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01872013
Start Date
November 1 2012
End Date
February 1 2013
Last Update
June 7 2013
Active Locations (1)
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1
Tokyo, Japan