A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder (TPIP) in Healthy Participants

• Status: Completed
• Trial end date: 2021-01-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Insmed Incorporated
• Treatments: Treprostinil

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.