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

NCT06091579 | Completed Phase 1 FDA Drug

• 1 other identifier: INS1009-102
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (5)

Part A (SAD Cohort 1): TPIP

EXPERIMENTAL

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

Part A (SAD Cohort 2): TPIP or Placebo

EXPERIMENTAL

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; Drug: Placebo

Part A (SAD Cohort 3): TPIP or Placebo

EXPERIMENTAL

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; Drug: Placebo

Part B (MAD Cohort 1): TPIP or Placebo

EXPERIMENTAL

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; Drug: Placebo

Part B (MAD Cohort 2): TPIP or Placebo

EXPERIMENTAL

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; Drug: Placebo

Interventions

Treprostinil Palmitil Inhalation Powder DRUG

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

Also known as: INS1009

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

Placebo DRUG

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

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insmed Incorporated: lead

Study Sites (1)

USA001

Austin, Texas, 78744, United States

Location

Related 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):5144-5157. doi: 10.1007/s12325-022-02296-x. Epub 2022 Sep 7.

  PMID: 36070132 RESULT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 19, 2023
• Study Start: September 17, 2020
• Primary Completion: January 12, 2021
• Study Completion: January 12, 2021
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)