Healthy Volunteers
Conditions
Brief summary
The primary purpose of this study is to evaluate the safety and tolerability of single and multiple doses of treprostinil palmitil inhalation powder in healthy participants.
Interventions
Oral inhalation using a Plastiape capsule-based dry powder inhaler.
DRUGPlacebo
Oral placebo inhalation using a Plastiape capsule-based dry powder inhaler.
Sponsors
Insmed Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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. Note: Other inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parts A and B: Number of Participants who Experienced an Adverse Event (AE) | Up to Day 31 in Part A and Day 37 in Part B | Safety and tolerability of single and multiple doses of treprostinil inhalation powder will be determined in healthy participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parts A and B: Area Under the Plasma Concentration Versus Time Curve (AUC) of Treprostinil | Part A: Predose and at multiple time points postdose up to Day 4; Part B: Predose and at multiple time points postdose up to Day 10 | Pharmacokinetics of treprostinil following a single and multiple doses will be assessed in healthy participants. |
| Parts A and B: Area Under the Plasma Concentration Versus Time Curve (AUC) of Treprostinil Palmitil | Part A: Predose and at multiple time points postdose up to Day 4; Part B: Predose and at multiple time points postdose up to Day 10 | Pharmacokinetics of treprostinil palmitil following a single and multiple doses will be assessed in healthy participants. |
Countries
United States
Outcome results
None listed