Drug-Drug Interaction Study of TRK-100STP | NCT00719758

Studies
Drug-Drug Interaction Study of TRK-100STP

NCT00719758

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Oct 13, 2008Estimated

Enrollment

24Actual

Phase

Phase 1

Conditions

Healthy

Interventions

TRK-100STP (BERASUS LA)
AST-120 (Kremezin®)

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

Oct 2008

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

Jun 2008

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Jul 18, 2008

First Submission Date that Met QC Criteria

Jul 21, 2008

First Posted Date

Jul 22, 2008Estimated

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

Oct 9, 2008

Last Update Posted Date

Oct 13, 2008Estimated

Name	Class
Toray Industries, Inc	INDUSTRY

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

The purpose of this study is to evaluate the effect of AST-120 on the PK of TRK-100STP, and to evaluate the safety and tolerability of TRK-100STP alone or in combination with AST-120

Detailed Description

Non-blinded, randomized and crossover study to evaluate pharmacokinetic interaction between TRK-100STP and AST-120 in different administration condition. Nonelderly adult volunteers will receive TRK-100STP with or without AS-T120 after meal. Safety parameters will concurrently be measured.

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
1	Experimental	Cross-over study	Drug: TRK-100STP (BERASUS LA) Drug: AST-120 (Kremezin®)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TRK-100STP (BERASUS LA)	Drug	oral	1	beraprost Careload LA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetic profile		1 day

Secondary Outcomes

Measure	Description	Time Frame
Safety parameters (vital signs, ECG, laboratory tests)		1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provision of written informed consent
Body Mass Index (BMI) of ≥17.6 to ≤26.4 kg/m2 and weight of ≥50 to ≤80 kg

Exclusion Criteria:

Clinical abnormal physical findings, including BP, pulse rate, ECG and laboratory assessments
Receives any investigational medicine within 120 days before screening
Recent blood donor

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
Central Contact	Astellas Pharma Inc	Study Chair

Intervention Browse Module

MeSH Terms

ID	Term
C048081	beraprost
C040896	AST 120

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided