Multiple Oral Administration of ASP7991 to Non-elderly Male Subjects
Randomized, Double-blinded, Placebo-controlled, Multiple Oral Administration of ASP7991 to Non-elderly Male Subjects
1 other identifier
interventional
36
1 country
1
Brief Summary
This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after multiple oral administrations to non-elderly subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Nov 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 5, 2013
CompletedFirst Posted
Study publicly available on registry
June 7, 2013
CompletedJune 7, 2013
June 1, 2013
3 months
June 5, 2013
June 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs, ECGs for QT evaluation and slit lamp examination
For 96 hours after dosing
Secondary Outcomes (2)
Plasma concentrations unchanged drug; AUC24h, Cmax, Ctrough, tmax, t1/2, CL/F, Vz/F
For 96 hours after dosing
Urinary concentrations unchanged drug; Aelast, Aelast%, CLR
For 96 hours after dosing
Study Arms (4)
low dose ASP7991
EXPERIMENTALmiddle dose ASP7991
EXPERIMENTALhigh dose ASP7991
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Tokyo, Japan
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2013
First Posted
June 7, 2013
Study Start
November 1, 2012
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
June 7, 2013
Record last verified: 2013-06