A Pharmacokinetic Substudy of the TDE-PH-304 Protocol

NCT01934582 | Completed Phase 3 Results

• 2 other identifiers: TDE-PH-309TDE-PH-304
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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)

  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.

  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).

  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.

  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)

Secondary Outcomes (2)

• To Assess 6-minute Walk Distance for Both Groups (BID and TID) 3 to 6 Hours Post-morning Dose.

  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]).

• To Compare the Adverse Event (AE) Profile of BID Versus TID Dosing.

  The AEs were recorded for up to 50 days.

Study Arms (1)

Open label extension

EXPERIMENTAL

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

Interventions

UT-15C SR DRUG

Open label extension

treprostinil diethanolamine DRUG

Open label study drug.

Also known as: UT-15C Sustained Release (SR)

Open label extension

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• The subject must voluntarily give informed consent to participate in the substudy.
• No dose changes to study drug are made within 5 days of the pharmacokinetic (PK)substudy visits.
• 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.
• 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.
• Subject dosing of study drug on the day of PK sampling must be observed in the clinic by study personnel.
• Subject has not experienced a significant loss of blood (\> 450 mL) within the last 6 weeks of the pharmacokinetic substudy visit.
• The subject must not be receiving any CYP 2C8 inducers or inhibitors

Sponsors & Collaborators

• United Therapeutics: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14623, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

treprostinil

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Global Medical Information
• Organization: United Therapeutics Corp.

clinicaltrials@unither.com

919-425-8350

Study Officials

• James R White, MD, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2013
• First Posted: September 4, 2013
• Study Start: August 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 3, 2024
• Results First Posted: October 27, 2016

Record last verified: 2016-09

Locations

US (1)