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

NCT ID: NCT01427387

Last Updated: 2011-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-09-30

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.

Detailed Description

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Conditions

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Healthy Pharmacokinetics of ASP0456

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Part-1 ASP group

ASP0456 receiving group

Group Type EXPERIMENTAL

ASP0456

Intervention Type DRUG

oral

Part-1 Placebo group

Placebo treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral

Part-2 group

cross-over study group to evaluate food effect on ASP0456 plasma concentration

Group Type EXPERIMENTAL

ASP0456

Intervention Type DRUG

oral

Interventions

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ASP0456

oral

Intervention Type DRUG

Placebo

oral

Intervention Type DRUG

Other Intervention Names

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linaclotide

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Use Cental Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

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Kantou, , Japan

Site Status

Countries

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Japan

Other Identifiers

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0456-CL-0012

Identifier Type: -

Identifier Source: org_study_id