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Completed

NCT Number: NCT07102316

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

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

USA001

Salt Lake City, Utah, 84124, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Note: Other protocol defined inclusion/exclusion criteria may apply.

Treatment and study plan

TPIP F2

Drug

Inhalation using a capsule-based dry powder inhaler device.

Other names: INS1009

TPIP F3

Drug

Inhalation using a capsule-based dry powder inhaler device.

Other names: INS1009

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Treprostinil (TRE)

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

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

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

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

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

Secondary outcomes

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

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

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

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

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

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

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

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

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

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

  6. Dose-Normalized Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable (AUClast/D) of TRE

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

  7. Dose-Normalized Cmax and Calculated as Cmax/Dose of TRE

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

  8. Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAEs)

    Time frame: Up to Day 17

Sponsors and collaborators

Lead sponsor

Insmed Incorporated

Industry

Registry information

Official study title

A Phase 1, Open-Label, Randomized, 3-Group, Crossover Study to Assess the Relative Bioavailability After a Single Inhalation Administration of TPIP Formulation 2 (F2) to TPIP Formulation 3 (F3) in Healthy Participants

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 3, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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