Healthy VolunteersPhase 1NCT06091579
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder (TPIP) in Healthy Participants
A Phase 1 study testing Treprostinil Palmitil Inhalation Powder in people with Healthy Volunteers, run by Insmed Incorporated at 1 site in United States.
Trial 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. 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?
- Treprostinil Palmitil Inhalation Powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2020to 12 Jan 2021
- 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
- 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.
Who cannot join
- 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).
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- 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.
- Note: Other inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, And Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Healthy Volunteers
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
- Being tested
- Treprostinil Palmitil Inhalation Powder, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treprostinil Palmitil Inhalation PowderDrug
Also called INS1009
Oral inhalation using a Plastiape capsule-based dry powder inhaler.
PlaceboDrug
Oral placebo inhalation using a Plastiape capsule-based dry powder inhaler.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Treprostinil Palmitil Inhalation Powder; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Pharmacokinetics of treprostinil following a single and multiple doses will be assessed in healthy participants.
Measured: 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
Pharmacokinetics of treprostinil palmitil following a single and multiple doses will be assessed in healthy participants.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start17 Sep 2020
- Primary completion12 Jan 2021
- Study completion12 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insmed Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091579
- Sponsor's protocol ID
- INS1009-102
- Status last verified
- Oct 2023
- First submitted
- 16 Oct 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36070132
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, And Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06091579
- Acronym / sponsor ID
- INS1009-102
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Insmed IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 12 Jan 2021 (actual)
- Study completion
- 12 Jan 2021 (actual)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A (SAD Cohort 1): TPIP | Experimental | Drug: Treprostinil Palmitil Inhalation PowderParticipants 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. |
| Part A (SAD Cohort 2): TPIP or Placebo | Experimental | Drug: Treprostinil Palmitil Inhalation Powder, Drug: PlaceboParticipants in SAD Cohort 2 received a single dose of TPIP at Dose D or matching placebo by oral inhalation on Day 1. |
| Part A (SAD Cohort 3): TPIP or Placebo | Experimental | Drug: Treprostinil Palmitil Inhalation Powder, Drug: PlaceboParticipants in SAD Cohort 3 received a single dose of TPIP at Dose E or matching placebo by oral inhalation on Day 1. |
| Part B (MAD Cohort 1): TPIP or Placebo | Experimental | Drug: Treprostinil Palmitil Inhalation Powder, Drug: PlaceboParticipants 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. |
| Part B (MAD Cohort 2): TPIP or Placebo | Experimental | Drug: Treprostinil Palmitil Inhalation Powder, Drug: PlaceboParticipants in MAD Cohort 2 received TPIP up to Dose D or matching placebo, QD by oral inhalation on Days 1 through 7. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treprostinil Palmitil Inhalation PowderAlso: INS1009Oral inhalation using a Plastiape capsule-based dry powder inhaler. | Drug | 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 |
| PlaceboOral placebo inhalation using a Plastiape capsule-based dry powder inhaler. | Drug | 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 |
Primary outcome
Parts A and B: Number of Participants who Experienced an Adverse Event (AE)
Time frame: Up to Day 31 in Part A and Day 37 in Part B
Safety and tolerability of single and multiple doses of treprostinil inhalation powder will be determined in healthy participants.
2 secondary outcomes
Parts A and B: Area Under the Plasma Concentration Versus Time Curve (AUC) of Treprostinil
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Results publication: PubMed 36070132Ismat 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treprostinil Palmitil Inhalation Powder 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 1 inclusion and 14 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 19 Oct 2023. 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?
Parts A and B: Number of Participants who Experienced an Adverse Event (AE) (time frame: Up to Day 31 in Part A and Day 37 in Part B). 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 NCT06091579, which also lists 1 linked publication.
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 19 Oct 2023.