Clincosm LogoSign in Get a demo

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

Sponsor
Insmed Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT06091579
Collaborator
(none)
42
Enrollment
1
Location
5
Arms
3.8
Actual Duration (Months)
10.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Treprostinil Palmitil Inhalation Powder
  • Drug: Placebo
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 17, 2020
Actual Primary Completion Date :
Jan 12, 2021
Actual Study Completion Date :
Jan 12, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part A (SAD Cohort 1): TPIP

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.

Drug: Treprostinil Palmitil Inhalation Powder
Oral inhalation using a Plastiape capsule-based dry powder inhaler.
Other Names:
  • INS1009

    		•
    Experimental: Part A (SAD Cohort 2): TPIP or Placebo

    Participants in SAD Cohort 2 received a single dose of TPIP at Dose D or matching placebo by oral inhalation on Day 1.

    Drug: Treprostinil Palmitil Inhalation Powder
    Oral inhalation using a Plastiape capsule-based dry powder inhaler.
    Other Names:
  • INS1009

    • Drug: Placebo
    Oral placebo inhalation using a Plastiape capsule-based dry powder inhaler.
    Experimental: Part A (SAD Cohort 3): TPIP or Placebo

    Participants in SAD Cohort 3 received a single dose of TPIP at Dose E or matching placebo by oral inhalation on Day 1.

    Drug: Treprostinil Palmitil Inhalation Powder
    Oral inhalation using a Plastiape capsule-based dry powder inhaler.
    Other Names:
  • INS1009

    • Drug: Placebo
    Oral placebo inhalation using a Plastiape capsule-based dry powder inhaler.
    Experimental: Part B (MAD Cohort 1): TPIP or 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.

    Drug: Treprostinil Palmitil Inhalation Powder
    Oral inhalation using a Plastiape capsule-based dry powder inhaler.
    Other Names:
  • INS1009

    • Drug: Placebo
    Oral placebo inhalation using a Plastiape capsule-based dry powder inhaler.
    Experimental: Part B (MAD Cohort 2): TPIP or Placebo

    Participants in MAD Cohort 2 received TPIP up to Dose D or matching placebo, QD by oral inhalation on Days 1 through 7.

    Drug: Treprostinil Palmitil Inhalation Powder
    Oral inhalation using a Plastiape capsule-based dry powder inhaler.
    Other Names:
  • INS1009

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 USA001 Austin Texas United States 78744

    Sponsors and Collaborators

    • Insmed Incorporated

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Insmed Incorporated
    ClinicalTrials.gov Identifier:
    NCT06091579
    Other Study ID Numbers:
    • INS1009-102
    First Posted:
    Oct 19, 2023
    Last Update Posted:
    Oct 19, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Respiratory Aspiration
    Treprostinil

    Study Results

    No Results Posted as of Oct 19, 2023