A Study to Assess the Relative Bioavailability After a Single Inhalation Administration of Treprostinil Palmitil Inhalation Powder (TPIP) Formulation 2 (F2) to TPIP Formulation 3 (F3) in Healthy Participants

NCT07102316 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: INS1009-103
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to determine the relative bioavailability of treprostinil (TRE) between the TPIP F2 and TPIP F3 at 3 capsule strengths, dose A, dose B, and dose C, in healthy participants following a single inhalation of TPIP dose.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax) of Treprostinil (TRE)

  Pre-dose and post-dose at multiple timepoints up to Day 10

• Area Under Plasma Concentration-Time Curve From 0 to Last Time Point With Quantifiable Concentration (AUClast) of TRE

  Pre-dose and post-dose at multiple timepoints up to Day 10

• Area Under Plasma Concentration-Time Curve From 0 to Infinity (AUCinf) of TRE

  Pre-dose and post-dose at multiple timepoints up to Day 10

Secondary Outcomes (8)

• Time to Reach Maximum Observed Plasma Concentration (Tmax) of TRE

  Pre-dose and post-dose at multiple timepoints up to Day 10

• Terminal Elimination Half-Life (t1/2) of TRE

  Pre-dose and post-dose at multiple timepoints up to Day 10

• Apparent Clearance Following Inhalation Administration (CL/F) of TRE

  Pre-dose and post-dose at multiple timepoints up to Day 10

• Apparent Volume of Distribution at Terminal Phase (Vz/F) of TRE

  Pre-dose and post-dose at multiple timepoints up to Day 10

• Dose-Normalized Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf/D) of TRE

  Pre-dose and post-dose at multiple timepoints up to Day 10

Study Arms (3)

TPIP Dose A

EXPERIMENTAL

Participants will receive single dose of TPIP F2 or F3 on Day 1 in treatment period 1 followed by single dose of TPIP F3 or F2 on Day 1 in treatment period 2. Both treatment periods are separated by 7-day washout period.

Drug: TPIP F2; Drug: TPIP F3

TPIP Dose B

EXPERIMENTAL

Participants will receive single dose of TPIP F2 or F3 on Day 1 in treatment period 1 followed by single dose of TPIP F3 or F2 on Day 1 in treatment period 2. Both treatment periods are separated by 7-day washout period.

Drug: TPIP F2; Drug: TPIP F3

TPIP Dose C

EXPERIMENTAL

Participants will receive single dose of TPIP F2 or F3 on Day 1 in treatment period 1 followed by single dose of TPIP F3 or F2 on Day 1 in treatment period 2. Both treatment periods are separated by 7-day washout period.

Drug: TPIP F2; Drug: TPIP F3

Interventions

TPIP F2 DRUG

Inhalation using a capsule-based dry powder inhaler device.

Also known as: INS1009

TPIP Dose A; TPIP Dose B; TPIP Dose C

TPIP F3 DRUG

Inhalation using a capsule-based dry powder inhaler device.

Also known as: INS1009

TPIP Dose A; TPIP Dose B; TPIP Dose C

Eligibility Criteria

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

You may qualify if:

• Body mass index (BMI): 18.0 to 32.0 kilogram per square metre (kg/m\^2), inclusive, at screening.
• Weight: ≥50 kg (kilograms), inclusive, at screening.
• Must be a nonsmoker (no use of tobacco or nicotine products) and/or has not used chewing tobacco for at least 1 month prior to screening.
• Participants must be able to inhale study treatment using a dry powder inhaler.
• All medication (including over-the-counter medication, health supplements such as St. John's wort extract) must have been stopped at least 14 days prior to clinical site admission. An exception is made for acetaminophen, which is allowed up to admission to the clinical facility. Female participants may continue to use hormonal contraceptives throughout the study.

You may not qualify if:

• Female participants who are pregnant, nursing, or planning to become pregnant during the study.
• Participant has a positive serology test result for human immunodeficiency virus 1 or 2, hepatitis C virus antibodies, or hepatitis B surface antigen or hepatitis B core antibodies at screening. A positive result for hepatitis C virus antibodies will be allowed, if the participant has documented proof of prior, successful treatment.
• History of malignancy within 5 years prior to screening, with exception of completely treated in situ carcinoma of the cervix, and completely treated non-metastatic squamous cell or basal cell carcinoma of the skin.
• Use of drugs that inhibit or induce Cytochrome P2C8 (CYP2C8) within 3 weeks prior to first dose until follow-up visit.
• Participant has received any study drug in another investigational study within 30 days of screening or less than 5 times the drug's half-life, whichever is longer.
• QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 450 milliseconds (ms).
• The participant had active liver disease or hepatic dysfunction at screening or admission, manifested as:
• Elevated liver function test results (Alanine Aminotransferase \[ALT\] or Aspartate Aminotransferase \[AST\] \> 2 × Upper Limit of Normal \[ULN\])
• Bilirubin \> 1.5 × ULN (isolated bilirubin \> 1.5 × ULN; ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%)
• Known hepatic or biliary abnormalities (excluding Gilbert's syndrome or asymptomatic gallstones)
• Participant has a platelet count less than lower limit of normal and/or a history of abnormal bleeding or bruising.
• Participant has a history of alcohol or drug abuse within 3 months before screening or excessive alcohol consumption (i.e., \> 21 units/week for males, \> 14 units/week for females) (1 unit is equal to approximately 1/2 pint \[200 milliliters (mL)\] of beer, 1 small glass \[100 mL\] of wine, or 1 measure \[25 mL\] of spirits).

Sponsors & Collaborators

• Insmed Incorporated: lead

Study Sites (1)

USA001

Salt Lake City, Utah, 84124, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 3, 2025
• Study Start: August 19, 2025
• Primary Completion: October 25, 2025
• Study Completion: November 3, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)