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A Pharmacokinetic Substudy of the TDE-PH-304 Protocol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01934582
First received: August 29, 2013
Last updated: September 6, 2016
Last verified: September 2016

August 29, 2013
September 6, 2016
August 2013
November 2013   (final data collection date for primary outcome measure)
  • To Assess the Pharmacokinetics (Mean AM Dose) in Subjects During Twice Daily (BID) Dosing (up to 14 Days Prior to Transitioning to Three Times Daily [TID] Dosing Regimen at PK Visit 1) and up to 35 Days After Transitioning to TID Dosing (at PK Visit 2). [ Time Frame: Up to 14 days prior to transitioning to TID dosing regimen (PK Visit 1) and up to 35 days after transitioning to TID dosing regiment (PK Visit 2) ] [ Designated as safety issue: No ]
    The PK sampling occurred over a 12-hour period in subjects during BID dosing (PK Visit 1) and during TID dosing (PK Visit 2). Prior to each PK sampling day, subjects must have been receiving a stable dose for at least 5 days.
  • To Assess the Pharmacokinetics (Cmax, Cmin) in Subjects During Twice Daily (BID) Dosing (up to 14 Days Prior to Transitioning to Three Times Daily [TID] Dosing Regimen at PK Visit 1) and up to 35 [ Time Frame: Up to 14 days prior to transitioning to TID dosing regimen (PK Visit 1) and up to 35 days after transitioning to TID dosing regiment (PK Visit 2) ] [ Designated as safety issue: No ]
    The PK sampling occurred over a 12-hour period in subjects during BID dosing (PK Visit 1) and during TID dosing (PK Visit 2). Prior to each PK sampling day, subjects must have been receiving a stable dose for at least 5 days.
  • To Assess the Pharmacokinetics (AUClast) in Subjects During Twice Daily (BID) Dosing (up to 14 Days Prior to Transitioning to Three Times Daily [TID] Dosing Regimen at PK Visit 1) and up to 35 Days After Transitioning to TID Dosing (at PK Visit 2). [ Time Frame: Up to 14 days prior to transitioning to TID dosing regimen (PK Visit 1) and up to 35 days after transitioning to TID dosing regiment (PK Visit 2) ] [ Designated as safety issue: No ]
    The PK sampling occurred over a 12-hour period in subjects during BID dosing (PK Visit 1) and during TID dosing (PK Visit 2). Prior to each PK sampling day, subjects must have been receiving a stable dose for at least 5 days.
To assess the pharmacokinetics of BID and TID dosing in subjects transitioning o this dosage regimen in study TDE-PH-304. [ Time Frame: Subjects will be enrolled for up to 50 days. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01934582 on ClinicalTrials.gov Archive Site
  • To Assess 6-minute Walk Distance for Both Groups (BID and TID) 3 to 6 Hours Post-morning Dose. [ Time Frame: The 6MWT was conducted during BID dosing PK collection (up to 14 days prior to transitioning to TID dosing regimen [PK Visit 1]) and during TID dosing PK collection (up to 35 days after transitioning to TID dosing regimen [PK Visit 2]). ] [ Designated as safety issue: No ]
    The 6-minute walk test (6MWT) was conducted at PK Visits 1 and 2, and was performed between hours 3 to 6 post-morning dose to correlate with the predicted peak plasma concentration of oral treprostinil.
  • To Compare the Adverse Event (AE) Profile of BID Versus TID Dosing. [ Time Frame: The AEs were recorded for up to 50 days. ] [ Designated as safety issue: Yes ]
    AE diaries including 8 therapy-specific terms were collected during both BID and TID dosing to allow for comparison of events from both regimens. The therapy-specific events included: diarrhea, extremity pain, flushing, headache, hypotension, jaw pain, nausea, and vomiting.
To assess 6MW distance for both groups (BID and TID) 3-6 hours post morning dose. [ Time Frame: Subjects will be enrolled for up to 50 days. ] [ Designated as safety issue: No ]
Not Provided
To compare the adverse event profile of twice daily (BID) versus three times daily (TID) dosing. [ Time Frame: Subjects will be enrolled up to 50 days. ] [ Designated as safety issue: No ]
 
A Pharmacokinetic Substudy of the TDE-PH-304 Protocol
A Pharmacokinetic Substudy of Subjects Transitioning From Twice Daily to Three Times Daily Dosing of UT-15C SR (Treprostinil Diethanolamine) in the TDE-PH-304 Protocol
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.
As noted above in "Brief Summary".
Interventional
Phase 3
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Pulmonary Arterial Hypertension
  • Drug: UT-15C SR
  • Drug: treprostinil diethanolamine
    Open label study drug.
    Other Name: UT-15C Sustained Release (SR)
Experimental: Open label extension
Interventions:
  • Drug: UT-15C SR
  • Drug: treprostinil diethanolamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
November 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

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 the pharmacokinetic substudy visit. Note: changes to diuretics and/or anticoagulants are permitted.
  4. The preceding evening dose of study drug should have been taken 9 to 13 hours prior to the BID dose and 6-10 hours prior to the TID morning dose of study drug to ensure a trough level of study drug for PK sampling.
  5. Subject dosing of study drug on the day of PK sampling must be observed in the clinic by study personnel.
  6. Subject has not experienced a significant loss of blood (> 450 mL) within the last 6 weeks of the pharmacokinetic substudy visit.
  7. The subject must not be receiving any CYP 2C8 inducers or inhibitors
Both
12 Years to 75 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01934582
TDE-PH-309, TDE-PH-304
No
Not Provided
Not Provided
United Therapeutics
United Therapeutics
Not Provided
Principal Investigator: James R White, MD, PhD University of Rochester
United Therapeutics
September 2016

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