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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 January 2024 |
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Main ID: |
NCT01934582 |
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Date of registration:
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29/08/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Pharmacokinetic Substudy of the TDE-PH-304 Protocol
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Scientific title:
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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 |
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Date of first enrolment:
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August 2013 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT01934582 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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James R White, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Rochester |
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Key inclusion & exclusion criteria
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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
Age minimum:
12 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: UT-15C SR
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Drug: treprostinil diethanolamine
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Primary Outcome(s)
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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)
[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)]
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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: 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)]
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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)]
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Secondary Outcome(s)
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To Compare the Adverse Event (AE) Profile of BID Versus TID Dosing.
[Time Frame: The AEs were recorded for up to 50 days.]
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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]).]
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Secondary ID(s)
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TDE-PH-304
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TDE-PH-309
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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