Three Times Daily Dosing of UT-15C

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01746485
First received: August 16, 2012
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Healthy
Drug: UT-15C
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A PK Evaluation of Three Times Daily Dosing of UT-15C SR Tablets in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • Area under the curve (AUC) from 0-24hrs after 6 days of TID dosing. [ Time Frame: 6 days ] [ Designated as safety issue: No ]
    Cmax, tmax, AUC(0-6), AUC(0-24), AUC(6-12), AUC(12-24) and t1/2


Secondary Outcome Measures:
  • PK profile of UT-15C after a single 0.5mg dose on Day 1 [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Day 1: Cmax, tmax, AUC(0-6), AUC(0-24), AUC(0-t), AUC(0-inf), and t1/2


Enrollment: 19
Study Start Date: July 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: UT-15C Drug: UT-15C
Other Names:
  • treprostinil diethanolamine
  • treprostinil diolamine
  • UT-15C SR

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746485

Locations
United States, Texas
PPD Development
Austin, Texas, United States
Sponsors and Collaborators
United Therapeutics
Investigators
Principal Investigator: Theresa Pham, MD PPD
  More Information

No publications provided by United Therapeutics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01746485     History of Changes
Other Study ID Numbers: TDE-DU-102
Study First Received: August 16, 2012
Last Updated: December 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by United Therapeutics:
Volunteers

Additional relevant MeSH terms:
Treprostinil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014