NCT00719758

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

October 13, 2008

Status Verified

October 1, 2008

Enrollment Period

3 months

First QC Date

July 18, 2008

Last Update Submit

October 9, 2008

Conditions

Healthy

Keywords

TRK-100STP,beraprost sodium,Careload LAAST-120Spherical carbon adsorbentDrug-drug interaction

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic profile

    1 day

Secondary Outcomes (1)

  • Safety parameters (vital signs, ECG, laboratory tests)

    1 day

Study Arms (1)

1

EXPERIMENTAL

Cross-over study

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

Interventions

TRK-100STP (BERASUS LA)DRUG

oral

Also known as: beraprost, Careload LA, BERASUS LA
1
AST-120 (Kremezin®)DRUG

oral

Also known as: Kremezin®, sopherical carbon adsorbent
1

Eligibility Criteria

Age20 Years - 44 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo, 108-8642, Japan

Location

MeSH Terms

Interventions

beraprostAST 120

Study Officials

  • Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 18, 2008

First Posted

July 22, 2008

Study Start

June 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

October 13, 2008

Record last verified: 2008-10

Locations

JP(1)