A Study to Evaluate Safety of Multiple Dose of ASP0456 in Healthy Subjects

Study Overview
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Brief Summary
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A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending dose of ASP0456 in non-elderly healthy subjects. Two dosing condition, pre-prandial and postprandial administrations, is compared.

Official Title
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Phase I Study of ASP0456 - A Double-blind, Placebo-controlled, Multiple Ascending Dose Study / Investigational Study for Dose Timing Selection in Non Elderly Healthy Subjects-

Conditions
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Healthy, Pharmacokinetics of ASP0456

Intervention / Treatment
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* Drug: ASP0456
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, as judged by the investigator/subinvestigator based on the results of physical examination and all tests obtained Body weight (at screening); female ≥40.0 kg,<70.0 kg male ≥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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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All

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part-1 ASP group<br>ASP0456 receiving group | Drug: ASP0456<br>* oral<br>* Other names: linaclotide;|
| Placebo Comparator: Part-1 Placebo group<br>Placebo treatment | Drug: Placebo<br>* oral<br>|
| Experimental: Part-2 group<br>cross-over study group to evaluate food effect on ASP0456 plasma concentration | Drug: ASP0456<br>* oral<br>* Other names: linaclotide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (such as Cmax, AUC and t1/2 etc.) of ASP0456 assessed by its plasma concentration change |  | For 48 hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and labo tests |  | For 48 hours after dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASP0456, Pharmacokinetics, safety, tolerability, food effect