- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01872013
Multiple Oral Administration of ASP7991 to Non-elderly Male Subjects
June 5, 2013 updated by: Astellas Pharma Inc
Randomized, Double-blinded, Placebo-controlled, Multiple Oral Administration of ASP7991 to Non-elderly Male Subjects
This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after multiple oral administrations to non-elderly subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 daily, the subjects are administered ASP7991 or placebo orally 30 minutes after breakfast with 150 mL water for 7 days.
After the each step the sponsor evaluates the safety in the blinded manner for deciding an escalation to the step.
Study Type
Interventional
Enrollment (Actual)
36
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
-
-
-
Tokyo, 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 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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 Criteria:
- 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)
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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
oral
|
Experimental: low dose ASP7991
|
oral
|
Experimental: middle dose ASP7991
|
oral
|
Experimental: high dose ASP7991
|
oral
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: For 96 hours after dosing
|
For 96 hours after dosing
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma concentrations unchanged drug; AUC24h, Cmax, Ctrough, tmax, t1/2, CL/F, Vz/F
Time Frame: For 96 hours after dosing
|
For 96 hours after dosing
|
Urinary concentrations unchanged drug; Aelast, Aelast%, CLR
Time Frame: For 96 hours after dosing
|
For 96 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
November 1, 2012
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
June 5, 2013
First Submitted That Met QC Criteria
June 5, 2013
First Posted (Estimate)
June 7, 2013
Study Record Updates
Last Update Posted (Estimate)
June 7, 2013
Last Update Submitted That Met QC Criteria
June 5, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7991-CL-1002
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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