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

NCT ID: NCT06091579

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-17
• Study Completion Date: 2021-01-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Treprostinil Palmitil Inhalation Powder

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Treprostinil Palmitil Inhalation Powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Treprostinil Palmitil Inhalation Powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Treprostinil Palmitil Inhalation Powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Treprostinil Palmitil Inhalation Powder

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

Interventions

Treprostinil Palmitil Inhalation Powder

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

INS1009

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Insmed Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

USA001

Austin, Texas, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 36070132 (View on PubMed)

Other Identifiers

INS1009-102

Identifier Type: -

Identifier Source: org_study_id