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

Primary Purpose

Healthy Volunteers

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Treprostinil Palmitil Inhalation Powder
Placebo
Sponsored by
Insmed Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Volunteers

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • USA001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Part A (SAD Cohort 1): TPIP

Part A (SAD Cohort 2): TPIP or Placebo

Part A (SAD Cohort 3): TPIP or Placebo

Part B (MAD Cohort 1): TPIP or Placebo

Part B (MAD Cohort 2): TPIP or Placebo

Arm Description

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.

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

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

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 16, 2023
Last Updated
October 16, 2023
Sponsor
Insmed Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT06091579
Brief Title
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder (TPIP) in Healthy Participants
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 17, 2020 (Actual)
Primary Completion Date
January 12, 2021 (Actual)
Study Completion Date
January 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insmed Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A (SAD Cohort 1): TPIP
Arm Type
Experimental
Arm Description
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.
Arm Title
Part A (SAD Cohort 2): TPIP or Placebo
Arm Type
Experimental
Arm Description
Participants in SAD Cohort 2 received a single dose of TPIP at Dose D or matching placebo by oral inhalation on Day 1.
Arm Title
Part A (SAD Cohort 3): TPIP or Placebo
Arm Type
Experimental
Arm Description
Participants in SAD Cohort 3 received a single dose of TPIP at Dose E or matching placebo by oral inhalation on Day 1.
Arm Title
Part B (MAD Cohort 1): TPIP or Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Part B (MAD Cohort 2): TPIP or Placebo
Arm Type
Experimental
Arm Description
Participants in MAD Cohort 2 received TPIP up to Dose D or matching placebo, QD by oral inhalation on Days 1 through 7.
Intervention Type
Drug
Intervention Name(s)
Treprostinil Palmitil Inhalation Powder
Other Intervention Name(s)
INS1009
Intervention Description
Oral inhalation using a Plastiape capsule-based dry powder inhaler.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral placebo inhalation using a Plastiape capsule-based dry powder inhaler.
Primary Outcome Measure Information:
Title
Parts A and B: Number of Participants who Experienced an Adverse Event (AE)
Description
Safety and tolerability of single and multiple doses of treprostinil inhalation powder will be determined in healthy participants.
Time Frame
Up to Day 31 in Part A and Day 37 in Part B
Secondary Outcome Measure Information:
Title
Parts A and B: Area Under the Plasma Concentration Versus Time Curve (AUC) of Treprostinil
Description
Pharmacokinetics of treprostinil following a single and multiple doses will be assessed in healthy participants.
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
Title
Parts A and B: Area Under the Plasma Concentration Versus Time Curve (AUC) of Treprostinil Palmitil
Description
Pharmacokinetics of treprostinil palmitil following a single and multiple doses will be assessed in healthy participants.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
USA001
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36070132
Citation
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):5144-5157. doi: 10.1007/s12325-022-02296-x. Epub 2022 Sep 7.
Results Reference
result

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

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