Skip to main content
OpenTrials
Completed

NCT Number: NCT06091579

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

USA001

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Treprostinil Palmitil Inhalation Powder

Drug

Oral inhalation using a Plastiape capsule-based dry powder inhaler.

Other names: INS1009

Placebo

Drug

Oral placebo inhalation using a Plastiape capsule-based dry powder inhaler.

Primary outcomes

  1. Parts A and B: Number of Participants who Experienced an Adverse Event (AE)

    Time frame: 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 outcomes

  1. Parts A and B: Area Under the Plasma Concentration Versus Time Curve (AUC) of Treprostinil

    Time frame: 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.

  2. Parts A and B: Area Under the Plasma Concentration Versus Time Curve (AUC) of Treprostinil Palmitil

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Insmed Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 19, 2023
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.