Treprostinil Palmitil Inhalation Powder Formulations for Bioavailability Study
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on how the body absorbs different strengths of an inhaled powder called Treprostinil Palmitil. It aims to determine which formulation best delivers the medicine into the bloodstream in healthy individuals. Participants will inhale a single dose, and researchers will compare results across different doses. The trial suits non-smokers who do not take regular medications, except for occasional acetaminophen, and can use a dry powder inhaler. As a Phase 1 trial, the research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the trial?
Yes, you must stop taking all medications, including over-the-counter ones and health supplements, at least 14 days before joining the trial, except for acetaminophen and hormonal contraceptives for women.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that Treprostinil Palmitil Inhalation Powder (TPIP) has undergone safety testing in people. In an earlier study, participants generally tolerated TPIP well when taken once a day, with most side effects being mild, such as a cough or sore throat. Another study involving individuals with Pulmonary Arterial Hypertension (a type of high blood pressure affecting the lungs) found similar mild side effects.
Although the current study is in its early stages, the fact that TPIP has been tested in more advanced trials suggests it is reasonably safe. However, it is important to note that this study is testing different doses and forms, so new safety information may emerge.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Treprostinil Palmitil Inhalation Powder because it offers a new delivery method for treating pulmonary arterial hypertension (PAH). Unlike existing treatments that are often delivered via injection or continuous infusion pumps, this formulation is inhaled, potentially making it more convenient and less invasive for patients. Additionally, the inhaled powder form could provide more direct delivery to the lungs, which might enhance the drug's effectiveness and reduce systemic side effects. This innovative approach could significantly improve patient adherence and quality of life compared to traditional methods.
What evidence suggests that this trial's treatments could be effective?
Research has shown that treprostinil palmitil inhalation powder (TPIP) may help treat pulmonary arterial hypertension (PAH). One study found that TPIP eased blood flow through the lungs by reducing resistance in the lung's blood vessels. After 16 weeks, patients using TPIP showed better results than those who did not. Early research also indicates that TPIP is safe and well-tolerated, whether taken once or multiple times. These findings suggest that TPIP could be a helpful treatment for PAH, improving lung function and easing breathing.
In this trial, participants will receive different formulations of TPIP in separate treatment arms to assess bioavailability. Each arm involves receiving a single dose of either TPIP F2 or F3, followed by a washout period, and then a single dose of the alternate formulation.13678Are You a Good Fit for This Trial?
This trial is for healthy adults with a BMI of 18.0 to 32.0 kg/m^2, weighing at least 50 kg, who can inhale medication using a dry powder inhaler and have not smoked or used nicotine products for at least one month. Participants must stop all medications except acetaminophen and hormonal contraceptives before joining.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of TPIP F2 or F3 on Day 1 in treatment period 1 followed by a single dose of TPIP F3 or F2 on Day 1 in treatment period 2, with a 7-day washout period between treatments
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Treprostinil Palmitil Inhalation Powder
Find a Clinic Near You
Who Is Running the Clinical Trial?
Insmed Incorporated
Lead Sponsor