Healthy VolunteersPhase 1NCT06193031
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of C16TR for Inhalation With Tyvaso® Cohort in Healthy Participants
A Phase 1 study testing C16TR and Tyvaso® 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 determine the safety and tolerability of escalating doses of C16TR for inhalation 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?
- C16TR and Tyvaso®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2015to 18 Dec 2015
- 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
- Have a body weight between 50 and 120 kg (females) or between 55 and 120 kg (males), inclusive, with a body mass index (BMI) between 19.0 and 32.0 kilograms per square meter (kg/m^2), inclusive, at screening.
- Have a medical history, physical examination, vital signs, electrocardiogram (ECG) and clinical laboratory results within normal limits or considered not clinically significant by the Investigator at screening.
- Do not take any systemic or topical prescription, or nonprescription (over-the-counter [OTC]) medication (acetaminophen or ibuprofen are permitted upon principal investigator [PI] discretion) within 2 weeks or 5 half-lives (whichever is longer) before first dose of the study drugs until discharge from the study (unless prescribed by the Investigator to treat an AE).
- Agree to abstain from consuming alcohol at least 3 days prior to in-clinic confinement until discharge from the study.
Who cannot join
- Have a history of anaphylaxis, a previous documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug.
- Have a clinically significant history of neurological, cardiovascular, respiratory, endocrine, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary, and/or musculoskeletal disease; glaucoma; a psychiatric disorder, or any other chronic disease, whether controlled by medication or not.
- Have a history of orthostatic hypotension, or unexplained syncope.
- Have a history of additional risk factors for Torsades de Pointes (eg, heart failure, family history of Long QT Syndrome).
- Are positive for human immunodeficiency virus (HIV) infection, hepatitis B surface antigen (HBsAg), or the hepatitis C virus (HCV) antibody at screening.
- Are users or former users of nicotine-containing products with > 10 pack-years of tobacco use history (including but not limited to cigarettes, cigars, and chewing or dipping tobacco), or users who stopped use or consumption (i.e., smoking, chewing, or pinching) of these nicotine-containing products less than 6 months before study drug administration or were using or had used topical or oral nicotine preparations for smoking cessation within the past 3 months before study drug administration.
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- Have a history of alcohol abuse or a history of or current impairment of organ function reasonably related to alcohol abuse.
- Have a history or current evidence of abuse of licit or illicit drugs or a positive urine test for drugs of abuse.
- Have a history of abnormal bleeding tendencies.
- Donated any plasma within 7 days prior to first dosing, or has donated blood in excess of 450 mL, or had significant blood loss within 56 days prior to first dosing.
- Have any flu-like syndrome or other respiratory infection within 2 weeks of Day 1 or having been vaccinated with an attenuated live virus within 4 weeks of Day 1.
- Have a history of major surgery within 4 weeks or minor surgery within 2 weeks of screening.
- 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, Double-Blind, Placebo-Controlled Single Ascending Dose Study of C16TR for Inhalation to Determine Its Safety, Tolerability, and Pharmacokinetics With an Open-label Tyvaso® Cohort in Healthy Volunteers
The primary purpose of this study is to determine the safety and tolerability of escalating doses of C16TR for inhalation in healthy participants.
- Conditions
- Healthy Volunteers
- Being tested
- C16TR, Placebo, Tyvaso®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C16TRDrug
Also called Hexadecyl-treprostinil
Administered as inhalation using a Philips Micro device inhaler.
PlaceboDrug
Phosphate buffered saline (PBS) administered using Philips Micro device inhaler.
Tyvaso®Drug
Also called Inhaled treprostinil
Administered as inhalation.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Tyvaso®+C16TR Dose A or Tyvaso®+Placebo | Experimental | Participants received a single dose of Tyvaso® on Day 1, then randomized to receive either a single dose of C16TR for inhalation (Dose A) or matching placebo on Day 2 in Cohort 1. Receives: Drug: C16TR; Drug: Placebo; Drug: Tyvaso® |
| Cohort 2: C16TR Dose B or Placebo | Experimental | Participants were randomized to receive a single dose of C16TR for inhalation (Dose B) or matching placebo on Day 1 in Cohort 2. Receives: Drug: C16TR; Drug: Placebo |
| Cohort 3: C16TR Dose C or Placebo | Experimental | Participants were randomized to receive a single dose of C16TR for inhalation (Dose C) or matching placebo on Day 1 in Cohort 3. Receives: Drug: C16TR; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who Experienced an Adverse Event (AE)
Safety and tolerability of escalating doses of C16TR for inhalation in healthy participants.
Measured: Up to 32 days
Secondary outcomes (3)
Area Under the Plasma Concentration-time Curve (AUC) of Treprostinil and C16TR Post C16TR for Inhalation Dose
Measured: At multiple timepoints post dose on Days 2 to 4
Cohort 1: AUC of Treprostinil Post Tyvaso® Dosing
Pharmacokinetics of treprostinil after Tyvaso® dosing in healthy participants will be assessed.
Measured: At multiple timepoints post dose on Days 1 and 2 for Cohort 1
Mean Change From Baseline in Corrected QT Interval by Fridericia (QTcF) for C16TR
Measured: Baseline up to Day 4 (Cohort 1) and Day 3 (Cohorts 2, 3, 4, and 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start17 Nov 2015
- Primary completion18 Dec 2015
- Study completion18 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 24 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
- NCT06193031
- Sponsor's protocol ID
- INS1009-101
- Status last verified
- Dec 2023
- First submitted
- 21 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study of C16TR for Inhalation to Determine Its Safety, Tolerability, and Pharmacokinetics With an Open-label Tyvaso® Cohort in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06193031
- Acronym / sponsor ID
- INS1009-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Insmed IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2015 (actual)
- Primary completion
- 18 Dec 2015 (actual)
- Study completion
- 18 Dec 2015 (actual)
- First posted
- 5 Jan 2024 (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 determine the safety and tolerability of escalating doses of C16TR for inhalation 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Tyvaso®+C16TR Dose A or Tyvaso®+Placebo | Experimental | Drug: C16TR, Drug: Placebo, Drug: Tyvaso®Participants received a single dose of Tyvaso® on Day 1, then randomized to receive either a single dose of C16TR for inhalation (Dose A) or matching placebo on Day 2 in Cohort 1. |
| Cohort 2: C16TR Dose B or Placebo | Experimental | Drug: C16TR, Drug: PlaceboParticipants were randomized to receive a single dose of C16TR for inhalation (Dose B) or matching placebo on Day 1 in Cohort 2. |
| Cohort 3: C16TR Dose C or Placebo | Experimental | Drug: C16TR, Drug: PlaceboParticipants were randomized to receive a single dose of C16TR for inhalation (Dose C) or matching placebo on Day 1 in Cohort 3. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Have a body weight between 50 and 120 kg (females) or between 55 and 120 kg (males), inclusive, with a body mass index (BMI) between 19.0 and 32.0 kilograms per square meter (kg/m^2), inclusive, at screening.
- Have a medical history, physical examination, vital signs, electrocardiogram (ECG) and clinical laboratory results within normal limits or considered not clinically significant by the Investigator at screening.
- Do not take any systemic or topical prescription, or nonprescription (over-the-counter [OTC]) medication (acetaminophen or ibuprofen are permitted upon principal investigator [PI] discretion) within 2 weeks or 5 half-lives (whichever is longer) before first dose of the study drugs until discharge from the study (unless prescribed by the Investigator to treat an AE).
- Agree to abstain from consuming alcohol at least 3 days prior to in-clinic confinement until discharge from the study.
Key exclusion criteria (13 listed)
- Have a history of anaphylaxis, a previous documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug.
- Have a clinically significant history of neurological, cardiovascular, respiratory, endocrine, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary, and/or musculoskeletal disease; glaucoma; a psychiatric disorder, or any other chronic disease, whether controlled by medication or not.
- Have a history of orthostatic hypotension, or unexplained syncope.
- Have a history of additional risk factors for Torsades de Pointes (eg, heart failure, family history of Long QT Syndrome).
- Are positive for human immunodeficiency virus (HIV) infection, hepatitis B surface antigen (HBsAg), or the hepatitis C virus (HCV) antibody 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 |
|---|---|---|
| C16TRAlso: Hexadecyl-treprostinilAdministered as inhalation using a Philips Micro device inhaler. | Drug | Cohort 1: Tyvaso®+C16TR Dose A or Tyvaso®+Placebo, Cohort 2: C16TR Dose B or Placebo, Cohort 3: C16TR Dose C or Placebo |
| PlaceboPhosphate buffered saline (PBS) administered using Philips Micro device inhaler. | Drug | Cohort 1: Tyvaso®+C16TR Dose A or Tyvaso®+Placebo, Cohort 2: C16TR Dose B or Placebo, Cohort 3: C16TR Dose C or Placebo |
| Tyvaso®Also: Inhaled treprostinilAdministered as inhalation. | Drug | Cohort 1: Tyvaso®+C16TR Dose A or Tyvaso®+Placebo |
Primary outcome
Number of Participants who Experienced an Adverse Event (AE)
Time frame: Up to 32 days
Safety and tolerability of escalating doses of C16TR for inhalation in healthy participants.
3 secondary outcomes
Area Under the Plasma Concentration-time Curve (AUC) of Treprostinil and C16TR Post C16TR for Inhalation Dose
Time frame: At multiple timepoints post dose on Days 2 to 4
Cohort 1: AUC of Treprostinil Post Tyvaso® Dosing
Time frame: At multiple timepoints post dose on Days 1 and 2 for Cohort 1
Mean Change From Baseline in Corrected QT Interval by Fridericia (QTcF) for C16TR
Time frame: Baseline up to Day 4 (Cohort 1) and Day 3 (Cohorts 2, 3, 4, and 5)
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 5 Jan 2024.
- 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 C16TR and Tyvaso® 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 4 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 5 Jan 2024. 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?
Number of Participants who Experienced an Adverse Event (AE) (time frame: Up to 32 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2024.