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Three Times Daily Dosing of UT-15C

Sponsor
United Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT01746485
Collaborator
(none)
19
Enrollment
1
Location
1
Arm

Study Details

Study Description

Brief Summary

To evaluate the pharmacokinetics of three-times daily dosing of UT-15C in healthy volunteers

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
A PK Evaluation of Three Times Daily Dosing of UT-15C SR Tablets in Healthy Subjects
Study Start Date :
Jul 1, 2012
Actual Primary Completion Date :
Jul 1, 2012
Actual Study Completion Date :
Jul 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: UT-15C

Drug: UT-15C
Other Names:
  • treprostinil diethanolamine
  • treprostinil diolamine
  • UT-15C SR

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Area under the curve (AUC) from 0-24hrs after 6 days of TID dosing. [6 days]

      Cmax, tmax, AUC(0-6), AUC(0-24), AUC(6-12), AUC(12-24) and t1/2

    Secondary Outcome Measures

    1. PK profile of UT-15C after a single 0.5mg dose on Day 1 [1 day]

      Day 1: Cmax, tmax, AUC(0-6), AUC(0-24), AUC(0-t), AUC(0-inf), and t1/2

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    • Healthy male and female subjects

    • aged 18-55 years of age;

    • weight between 50 and 100 kg, with a body mass index (BMI) between 19.0 and 29.9 kg/m2, inclusive for female subjects and

    • weight between 50 and 120 kg, with a BMI between 19.0 and 32.0 kg/m², inclusive for male subjects.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 PPD Development Austin Texas United States

    Sponsors and Collaborators

    • United Therapeutics

    Investigators

    • Principal Investigator: Theresa Pham, MD, PPD

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    United Therapeutics
    ClinicalTrials.gov Identifier:
    NCT01746485
    Other Study ID Numbers:
    • TDE-DU-102
    First Posted:
    Dec 11, 2012
    Last Update Posted:
    Dec 12, 2012
    Last Verified:
    Dec 1, 2012
    Keywords provided by United Therapeutics
    Volunteers
    Additional relevant MeSH terms:
    Treprostinil

    Study Results

    No Results Posted as of Dec 12, 2012