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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06091579
• Other study ID #: INS1009-102
• Status: Completed
• Phase: Phase 1
• Start date: September 17, 2020
• Est. completion date: January 12, 2021

Study information

• Verified date: October 2023
• Source: Insmed Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 12, 2021
• Est. primary completion date: January 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers
• Respiratory Aspiration

Intervention

Drug:
• Treprostinil Palmitil Inhalation Powder
Oral inhalation using a Plastiape capsule-based dry powder inhaler.
• Placebo
Oral placebo inhalation using a Plastiape capsule-based dry powder inhaler.

Locations

Country	Name	City	State
United States	USA001	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Insmed Incorporated

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parts A and B: Number of Participants who Experienced an Adverse Event (AE)	Safety and tolerability of single and multiple doses of treprostinil inhalation powder will be determined in healthy participants.	Up to Day 31 in Part A and Day 37 in Part B
Secondary	Parts A and B: Area Under the Plasma Concentration Versus Time Curve (AUC) of Treprostinil	Pharmacokinetics of treprostinil following a single and multiple doses will be assessed in healthy participants.	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
Secondary	Parts A and B: Area Under the Plasma Concentration Versus Time Curve (AUC) of Treprostinil Palmitil	Pharmacokinetics of treprostinil palmitil following a single and multiple doses will be assessed in healthy participants.	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