A Pharmacokinetic Substudy of the TDE-PH-304 Protocol

Last updated: December 12, 2023
Sponsor: United Therapeutics
Overall Status: Completed

Phase

3

Condition

Williams Syndrome

Vascular Diseases

Circulation Disorders

Treatment

treprostinil diethanolamine

UT-15C SR

Clinical Study ID

NCT01934582
TDE-PH-309
TDE-PH-304
  • Ages 12-75
  • All Genders

Study Summary

A sub-study to the TDE-PH-304 protocol to assess the pharmacokinetics of patients transitioning from a twice daily dosing regimen of oral treprostinil to a three times daily dosing regimen.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Only subjects who are eligible for and have entered into Protocol TDE-PH-304 mayparticipate in this substudy.

Exclusion

Exclusion Criteria:

  1. The subject must voluntarily give informed consent to participate in the substudy.
  2. No dose changes to study drug are made within 5 days of the pharmacokinetic (PK)substudy visits.
  3. No additions or deletions to concurrent medications are made within 7 days of thepharmacokinetic substudy visit. Note: changes to diuretics and/or anticoagulants arepermitted.
  4. The preceding evening dose of study drug should have been taken 9 to 13 hours prior tothe BID dose and 6-10 hours prior to the TID morning dose of study drug to ensure atrough level of study drug for PK sampling.
  5. Subject dosing of study drug on the day of PK sampling must be observed in the clinicby study personnel.
  6. Subject has not experienced a significant loss of blood (> 450 mL) within the last 6weeks of the pharmacokinetic substudy visit.
  7. The subject must not be receiving any CYP 2C8 inducers or inhibitors

Study Design

Total Participants: 13
Treatment Group(s): 2
Primary Treatment: treprostinil diethanolamine
Phase: 3
Study Start date:
August 01, 2013
Estimated Completion Date:
November 30, 2013

Study Description

As noted above in "Brief Summary".

Connect with a study center

  • University of Rochester Medical Center

    Rochester, New York 14623
    United States

    Site Not Available

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