A Pharmacokinetic Substudy of the TDE-PH-304 Protocol

United Therapeutics

Status and phase: Completed; Phase 3

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: treprostinil diethanolamine; Drug: UT-15C SR

Study type: Interventional

Funder types: Industry

Identifiers

NCT01934582

TDE-PH-304

TDE-PH-309

Details and patient eligibility

About

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.

Full description

As noted above in "Brief Summary".

Enrollment: 13 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Open label extension

Experimental group

Treatment:

Drug: UT-15C SR

Drug: treprostinil diethanolamine