Phase 3
Completed N=13
A Pharmacokinetic Substudy of the TDE-PH-304 Protocol
Source: ClinicalTrials.gov NCT01934582 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcomePrimary: 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). — 8.12; 6.75 mg
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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). |
8.12; 6.75 | — |
| PRIMARY 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) |
8.60; 8.94; 1.19; 2.14 | — |
| PRIMARY 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). |
47.8; 58.0 | — |
| SECONDARY To Assess 6-minute Walk Distance for Both Groups (BID and TID) 3 to 6 Hours Post-morning Dose. |
332.5; 347.9 | — |
| SECONDARY To Compare the Adverse Event (AE) Profile of BID Versus TID Dosing. |
46; 38; 54; 38; 85; 54 | — |
Eligibility Criteria
Inclusion Criteria
- Only subjects who are eligible for and have entered into Protocol TDE-PH-304 may participate in this substudy.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01934582). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.