AzTrials
AzTrials

Healthy VolunteersPhase 1NCT07102316

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

A Phase 1 study testing TPIP F2 and TPIP F3 in people with Healthy Volunteers, run by Insmed Incorporated at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
TPIP F2 and TPIP F3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteUnited States
Study dates
19 Aug 2025to 3 Nov 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • USA001

    Salt Lake City, Utah, 84124

Other trials in United States

About this study

Official 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

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.

Being tested
TPIP F2, TPIP F3

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TPIP F2Drug

    Also called INS1009

    Inhalation using a capsule-based dry powder inhaler device.

  • TPIP F3Drug

    Also called INS1009

    Inhalation using a capsule-based dry powder inhaler device.

Study groups in NCT07102316
Study groupRoleWhat they receive
TPIP Dose AExperimentalParticipants 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.
Receives: Drug: TPIP F2; Drug: TPIP F3
TPIP Dose BExperimentalParticipants 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.
Receives: Drug: TPIP F2; Drug: TPIP F3
TPIP Dose CExperimentalParticipants 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.
Receives: Drug: TPIP F2; Drug: TPIP F3

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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

    Measured: 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

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

Secondary outcomes (8)

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

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

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

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

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

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

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

    Measured: 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

    Measured: 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

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

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

    Measured: 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)

    Measured: Up to Day 17

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2025
  2. Study start19 Aug 2025
  3. Primary completion25 Oct 2025
  4. Study completion3 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07102316
Sponsor's protocol ID
INS1009-103
Status last verified
Nov 2025
First submitted
28 Jul 2025
Last updated
21 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TPIP F2 and TPIP F3 in people with Healthy Volunteers, run by Insmed Incorporated at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Concentration (Cmax) of Treprostinil (TRE) (time frame: Pre-dose and post-dose at multiple timepoints up to Day 10). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07102316.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.

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