Multiple Oral Administration of ASP7991 to Non-elderly Male Subjects

Study Overview
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Brief Summary
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This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after multiple oral administrations to non-elderly subjects.

Detailed Description
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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.

Official Title
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Randomized, Double-blinded, Placebo-controlled, Multiple Oral Administration of ASP7991 to Non-elderly Male Subjects

Conditions
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Healthy, Pharmacokinetics of ASP7991

Intervention / Treatment
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* Drug: ASP7991
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low dose ASP7991<br> | Drug: ASP7991<br>* oral<br>|
| Experimental: middle dose ASP7991<br> | Drug: ASP7991<br>* oral<br>|
| Experimental: high dose ASP7991<br> | Drug: ASP7991<br>* oral<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | For 96 hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plasma concentration, Urinary concentration, ASP7991