Clareo Health | A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder (TPIP) in Healthy Participants
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Insmed Incorporated
Age
18–45
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
The participant is considered by the investigator to be in good general health as determined by medical history, physical examination findings, vital sign measurements, 12-lead electrocardiogram (ECG) results, and clinical laboratory test results within normal limits or considered not clinically significant by the investigator, at screening.
You may not be if
The participant has an allergy, documented hypersensitivity, or contraindication to the ingredients or to any of the excipients of treprostinil palmitil inhalation powder or treprostinil.
The participant has used any prescription (excluding hormonal birth control) or over-the-counter medications, including herbal or nutritional supplements, within 14 days before the first dose of study drug and throughout the study.
The participant has a history of anaphylaxis, previously documented hypersensitivity reaction to any drug.
The participant has had a surgical procedure that required general anesthesia (or equivalent) within 90 days prior to screening.
The participant has a body mass index \<19.0 or \>32.0 kilograms per square meter (kg/m\^2) at screening.
The participant has a history of syncope not due to dehydration or vasovagal syncope (eg, congenital cardiac arrhythmias such as Wolff-Parkinson-White syndrome, nodal tachycardia, ventricular tachycardia, etc).
The participant has active liver disease or hepatic dysfunction at screening or check-in visits.
The participant has a history of human immunodeficiency virus (HIV) infection.
The participant has a history of abnormal bleeding or bruising.
The participant has a history of malignancy in the past 5 years, with exception of nonmelanoma skin cancer.
The participant has a current history (within the past 12 months) of substance and/or alcohol abuse.
The participant is a current user of cigarettes (average of ≥1 cigarette/day) or e-cigarettes within 30 days prior to screening.
The participant has a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking) at screening or before the first dose of study drug or throughout the study.
