A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder (TPIP) in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Drug: Placebo
- Registration Number
- NCT06091579
- Lead Sponsor
- Insmed Incorporated
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A (SAD Cohort 1): TPIP Treprostinil Palmitil Inhalation Powder Participants in the single ascending dose (SAD) Cohort 1 received a single dose of TPIP at Dose A, Dose B, or Dose C by oral inhalation on Day 1. Part A (SAD Cohort 2): TPIP or Placebo Treprostinil Palmitil Inhalation Powder Participants in SAD Cohort 2 received a single dose of TPIP at Dose D or matching placebo by oral inhalation on Day 1. Part A (SAD Cohort 2): TPIP or Placebo Placebo Participants in SAD Cohort 2 received a single dose of TPIP at Dose D or matching placebo by oral inhalation on Day 1. Part B (MAD Cohort 2): TPIP or Placebo Placebo Participants in MAD Cohort 2 received TPIP up to Dose D or matching placebo, QD by oral inhalation on Days 1 through 7. Part A (SAD Cohort 3): TPIP or Placebo Treprostinil Palmitil Inhalation Powder Participants in SAD Cohort 3 received a single dose of TPIP at Dose E or matching placebo by oral inhalation on Day 1. Part A (SAD Cohort 3): TPIP or Placebo Placebo Participants in SAD Cohort 3 received a single dose of TPIP at Dose E or matching placebo by oral inhalation on Day 1. Part B (MAD Cohort 1): TPIP or Placebo Treprostinil Palmitil Inhalation Powder Participants in the multiple ascending dose (MAD) Cohort 1 received TPIP at Dose B, Dose C or matching placebo, once daily (QD) by oral inhalation on Days 1 through 7. Part B (MAD Cohort 1): TPIP or Placebo Placebo Participants in the multiple ascending dose (MAD) Cohort 1 received TPIP at Dose B, Dose C or matching placebo, once daily (QD) by oral inhalation on Days 1 through 7. Part B (MAD Cohort 2): TPIP or Placebo Treprostinil Palmitil Inhalation Powder Participants in MAD Cohort 2 received TPIP up to Dose D or matching placebo, QD by oral inhalation on Days 1 through 7.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (1)
USA001
🇺🇸Austin, Texas, United States