A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Par… (NCT05176951) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
The primary objective of this study is to evaluate the safety and tolerability of treprostinil palmitil inhalation powder (TPIP) compared with placebo
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Males and females must be ≥ 18 to ≤ 80 years of age at the time of signing the informed consent form (ICF).
* Diagnosis of pulmonary hypertension (PH) associated with interstitial lung disease (ILD) (including idiopathic interstitial pneumonia \[IIP\], idiopathic pulmonary fibrosis \[IPF\], connective tissue disease \[CTD\], sarcoidosis).
* Male and female participants must use contraceptives that are consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Male participants:
Male participants who are not sterile, with female partners of childbearing potential, must be using effective contraception from Day 1 to at least 90 days after the last dose of study drug.
Male participants with women of child bearing potential (WOCBP) partner must use a condom in order to avoid potential exposure to embryo/fetus.
\- Female participants: Women must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, (ie,hysterectomy and/or bilateral salpingo-oophorectomy) or using highly effective contraception methods (ie, methods that alone or in combination achieve \<1% unintended pregnancy rates per year when used consistently and correctly) from Day 1 to at least 90 days after the last dose of study drug.
\- Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the ICF and in this protoco…
What they're measuring
1
Number of Participants Who Experience Any Number of Treatment Emergent Adverse Events (TEAEs)
Timeframe: Up to Day 140
2
Number of Participants Who Experience Any Number of Serious Adverse Events (SAEs)
Timeframe: Up to Day 140
3
Change from Baseline in Saturation of Peripheral Capillary Oxygenation (SpO2) Levels
Timeframe: Pre-, during, and post- 6-minute walk test (6MWT) at Baseline, Week 5, Week 10, and Week 16