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Drug-Drug Interaction Study of TRK-100STP

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT00719758
Collaborator
Toray Industries, Inc (Industry)
24
Enrollment
1
Location
1
Arm
3
Duration (Months)
7.9
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: TRK-100STP (BERASUS LA)
  • Drug: AST-120 (Kremezin®)
 Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
TRK-100STP Pharmacokinetic Study in Healthy Volunteers - Evaluation of Pharmacokinetic Interaction Between TRK-100STP and Kremezin
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Cross-over study

Drug: TRK-100STP (BERASUS LA)
oral
Other Names:
  • beraprost
  • Careload LA
  • BERASUS LA

    • Drug: AST-120 (Kremezin®)
    oral
    Other Names:
  • Kremezin®
  • sopherical carbon adsorbent

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetic profile [1 day]

    Secondary Outcome Measures

    1. Safety parameters (vital signs, ECG, laboratory tests) [1 day]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 44 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tokyo Japan 108-8642

    Sponsors and Collaborators

    • Astellas Pharma Inc
    • Toray Industries, Inc

    Investigators

    • Study Chair: Central Contact, Astellas Pharma Inc

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00719758
    Other Study ID Numbers:
    • 533-CL-005
    First Posted:
    Jul 22, 2008
    Last Update Posted:
    Oct 13, 2008
    Last Verified:
    Oct 1, 2008
    Keywords provided by , ,
    TRK-100STP,
    beraprost sodium,
    Careload LA
    AST-120
    Spherical carbon adsorbent
    Drug-drug interaction
    Additional relevant MeSH terms:
    Beraprost

    Study Results

    No Results Posted as of Oct 13, 2008