Clinical trial

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

NCT01934582

Name

TDE-PH-309

Description

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.

Trial arms

Trial start

2013-08-01

Estimated PCD

2013-11-01

Trial end

2013-11-01

Status

Completed

Phase

Early phase I

Treatment

UT-15C SR

Arms:

Open label extension

treprostinil diethanolamine

Open label study drug.

Arms:

Open label extension

Other names:

UT-15C Sustained Release (SR)

Size

Primary endpoint

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).

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)

To Assess the Pharmacokinetics (Cmax, Cmin) in Subjects During BID Dosing (up to 14 Days Prior to Transitioning to TID Dosing Regimen at PK Visit 1) and up to 35 Days After Transitioning to TID Dosing Regiment (PK Visit 2)

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)

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).

0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose at up to 14 days prior to transitioning to TID dosing regimen (PK Visit 1) and at up to 35 days after transitioning to TID dosing regiment (PK Visit 2)

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 13, 'type': 'ACTUAL'}}

Updated at

2024-01-03

1 organization

2 products

1 indication

Product

UT-15C

Indication

Pulmonary Arterial Hypertension

Product

Treprostinil diethanolamine

Organization

United Therapeutics