A Safety and Pharmacokinetics Study of ASP0456 in Healthy... | NCT01279915

Studies
A Safety and Pharmacokinetics Study of ASP0456 in Healthy Subjects

NCT01279915

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Jan 20, 2011Estimated

Enrollment

32Actual

Phase

Phase 1

Conditions

Healthy
Pharmacokinetics of ASP0456

Interventions

ASP0456
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Jan 18, 2011

First Submission Date that Met QC Criteria

Jan 18, 2011

First Posted Date

Jan 20, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2011

Last Update Posted Date

Jan 20, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending dose of ASP0456 in non-elderly healthy subjects.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ASP group	Experimental	ASP0456 receiving group	Drug: ASP0456
Placebo group	Placebo Comparator	Placebo treatment	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ASP0456	Drug	oral	ASP group	linaclotide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetics of ASP0456 assessed by its plasma concentration change		For 48 hours after dosing

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy, as judged by the investigator/subinvestigator based on the results of physical examination and all tests obtained
Body weight (at screening); ≥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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Use Central Contact	Astellas Pharma Inc	Study Chair

Intervention Browse Module

MeSH Terms

ID	Term
C523483	linaclotide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided