Clinical trial NCT06091579: A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder (TPIP) in Healthy Participants
Official title: A Phase 1, Randomized, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, And Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Insmed Incorporated
Sponsor class: INDUSTRY
First posted: 2023-10-19
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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/exclusion criteria may apply.

Primary outcomes:
measure: Parts A and B: Number of Participants who Experienced an Adverse Event (AE)
timeFrame: Up to Day 31 in Part A and Day 37 in Part B
Secondary outcomes:
measure: Parts A and B: Area Under the Plasma Concentration Versus Time Curve (AUC) of Treprostinil
timeFrame: 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
measure: Parts A and B: Area Under the Plasma Concentration Versus Time Curve (AUC) of Treprostinil Palmitil
timeFrame: 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
Other outcomes:
Locations:
city: Austin
country: United States
facility: USA001
state: Texas
Study officials:
References:
citation: Ismat FA, Usansky HH, Villa R, Zou J, Teper A. Safety, Tolerability, and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder for Pulmonary Hypertension: A Phase 1, Randomized, Double-Blind, Single- and Multiple-Dose Study. Adv Ther. 2022 Nov;39(11):5144-5157. doi: 10.1007/s12325-022-02296-x. Epub 2022 Sep 7.