A non-randomized, single-center, open, two-period study with paired design to compare measured steady-state treprostinil concentrations in human plasma under treatment with a 10 mg/ml treprostinil formulation and following a switch to a 20 mg/ml treprostinil formulation in patients with pulmonary arterial hypertension (PAH)

Phase 1

• Conditions: pulmonary arterial hypertension; MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-004002-21-AT
• Lead Sponsor: AOP Orphan Pharmaceuticals GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-06
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

- Signed informed consent form
- Male or Female, aged 18 years at screening or above
- Patient is treated with 10 mg/ml treprostinil since at least two weeks on stable dose with no dose escalation planned for at least two more weeks
- Patient is on stable dose of at least 15 ng/kg/min since at least 2 weeks with an even number as programmed flow rate
- Patient is diagnosed with PAH (Group 1)
- Patient is in stable health condition
- Any concomitant medication has been maintained on stable dose since at least 72 hours
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients receiving any other strength of treprostinil
- Patients diagnosed with any other form of PH (e.g. CTEPH)
- Patient with signs of disease progression or worsening requiring up-titration of dose
- Patient shows signs of acute infusion site infection
- Patient reports infusion site pain scale > 3 (5-scale intensity score) at time of screening
- Patient has a history of serious adverse drug reactions possibly related to treprostinil
- Patient was diagnosed with severe hepatic or renal impairments or any other disease possibly impacting PK of treprostinil
- History of non-compliance
- Currently smoking > 10 cigarettes per day
- History of alcohol or drug abuse
- Pregnant or lactating women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the interchangeability of 20 mg/ml treprostinil compared to a 10 mg/ml treprostinil formulation by using pharmacokinetic (PK) endpoints. ;Secondary Objective: To evaluate the comparability of local tolerance of 10 mg/ml treprostinil and 20 mg/ml treprostinil ;Primary end point(s): Average concentration of Treprostinil at steady state Cavgss (= AUC0-t / t) ;Timepoint(s) of evaluation of this end point: Average concentration over a period of 24 hours (24 hours period 1 and 24 hours period 2)<br>Sampling will be performed after 0, 2, 4, 6, 8, 12, 24, 26, 28, 30, 32, 36, and 48 hours

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Number and frequency of local adverse drug reactions related to infusion site<br>- Average pain scale score <br>;Timepoint(s) of evaluation of this end point: Adverse Drug Reactions will be monitored and reported throughout study participation<br>Pain scale will be assessed after 4, 24, 28 and 48 hours