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(352) 733-0111

Evaluate the Efficacy, Safety and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder

  • Status
    Accepting Candidates
  • Age
    18 Years - 75 Years
  • Sexes
    All
  • Healthy Volunteers
    No
I'm interested
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Objective

The main objective of the study is to assess the effect of treprostinil palmitil inhalation powder (TPIP) compared with placebo on pulmonary vascular resistance.

Details

Full study title A Phase 2b, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Arterial Hypertension
Protocol number OCR41220
ClinicalTrials.gov ID NCT05147805
Phase Phase 2

Eligibility

Inclusion Criteria:

  • Participants must be ≥ 18 to ≤ 75 years at the time of signing the informed consent form (ICF).

  • Participants must have a diagnosis of World Health Organization (WHO) Group 1 Pulmonary Hypertension (PH) [pulmonary arterial hypertension (PAH)] in any of the

Following subtypes:

  1. Idiopathic

  2. Heritable

  3. Drug/toxin-induced or connective tissue disease (CTD)-associated PAH

  4. Congenital heart disease-related with simple systemic-to-pulmonary shunt at least 1 year following repair.

  • PAH diagnosis for at least 3 months.

  • Participants must be on stable PH therapy consisting of up to 2 medications from the

Following classes:

  1. Endothelin receptor antagonists (eg, ambrisentan, bosentan, macitentan)

  2. Phosphoesterase type 5 inhibitors (eg, sildenafil, tadalafil)

  3. Guanylate cyclase stimulator (eg, riociguat)

  • No change in PH medications (eg, ambrisentan, bosentan, macitentan, sildenafil, tadalafil, riociguat) or dosage for at least 30 days prior to Screening.

  • No change in long-term diuretic use or dosage for at least 30 days prior to Screening.

  • Body Mass Index (BMI) within the range 18.0-37.0 kg/m^2 (inclusive).

  • Male participants: Male participants who are not sterile and have 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.

  • Female participants: Women must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, (ie, post-tubal ligation for at least 12 months) or using highly effective contraception methods (ie, methods that alone or in combination achieve

Lead researcher

  • Ali Ataya, MD
    Critical Care Medicine Specialist, Pulmonologist (Lung Specialist)
    Ali Ataya

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.