A Study to Assess the Effect of ASP1585 on Pharmacokineti... | NCT01115985

Studies
A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Atorvastatin in Healthy Volunteers

NCT01115985

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

May 27, 2010Estimated

Enrollment

24Actual

Phase

Phase 1

Conditions

Healthy
Pharmacokinetics of Atorvastatin

Interventions

ASP1585
atorvastatin

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

May 2010

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

Mar 2010

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

May 3, 2010

First Submission Date that Met QC Criteria

May 3, 2010

First Posted Date

May 4, 2010Estimated

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

May 26, 2010

Last Update Posted Date

May 27, 2010Estimated

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

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

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
single-add first group	Experimental	single administration first, then concomitant administration	Drug: ASP1585 Drug: atorvastatin
combi-add first group	Experimental	concomitant administration first, then single administration	Drug: ASP1585 Drug: atorvastatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ASP1585	Drug	oral	combi-add first group single-add first group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma concentration of atorvastatin		48 hours after administration

Secondary Outcomes

Measure	Description	Time Frame
Safety assessed by AE, vital signs 12-lead ECG and lab tests		7 days after administration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Body weight: =<50.0kg, <80.0kg
Body mass index: =<17.6, <26.4
Healthy as judged by investigator or caregiver from subjective and objective symptoms and physical examination data

Exclusion Criteria:

Attending another clinical trial within 120 days before the study
Blood donation within 90 days (400ml) or 30 days (200ml) before the study
Receiving any drugs within 7 days before the study
History of allergy to drugs
Having GI disorders
History or complication of liver diseases
History or complication of heart disease
History or complication of respiratory diseases
History or complication of renal diseases
History or complication of cerebrovascular diseases

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
D000069059	Atorvastatin

Ancestor Terms

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided