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

August 16, 2012
December 10, 2012
July 2012
July 2012   (final data collection date for primary outcome measure)
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
Steady-state pharmacokinetics following repeat doses of 0.5mg UT-15C three times daily [ 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
Complete list of historical versions of study NCT01746485 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Three Times Daily Dosing of UT-15C
A PK Evaluation of Three Times Daily Dosing of UT-15C SR Tablets in Healthy Subjects

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

Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Healthy
Drug: UT-15C
Other Names:
  • treprostinil diethanolamine
  • treprostinil diolamine
  • UT-15C SR
Experimental: UT-15C
Intervention: Drug: UT-15C
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
July 2012
July 2012   (final data collection date for primary outcome measure)
  • 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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01746485
TDE-DU-102
No
United Therapeutics
United Therapeutics
Not Provided
Principal Investigator: Theresa Pham, MD PPD
United Therapeutics
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP