Healthy ParticipantsPhase 1INS1007NCT06344728
A Study to Assess the Relative Bioavailability of Brensocatib Pediatric Oral Solution to Oral Tablets in Healthy Participants
A Phase 1 study testing Brensocatib Oral Solution and Brensocatib Oral Tablet in people with Healthy Participants, run by Insmed Incorporated at 1 site in United States.
Trial summary
The primary purpose of this study is to determine the relative bioavailability of brensocatib between the pediatric oral solution and oral tablets in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Brensocatib Oral Solution and Brensocatib Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2024to 24 May 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index between 18.0 and 32.0 kilogram per square meter (kg/m^2), and a body weight of ≥ 50 kilogram (kg) at Screening.
- Female participants of childbearing potential must have a negative urine or serum pregnancy test at Screening and Day -1 and agree to contraceptive requirements.
- To be a non-smoker and has not used chewing tobacco for at least 3 months prior to screening.
- Women must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or using highly effective contraception from Screening to at least 30 days after discharge.
- Male participants must be on a stable method of contraception starting at Screening and continuing to at least 30 days after discharge.
Who cannot join
- History of stomach, gall bladder, or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
- Administration of a coronavirus disease 2019 vaccine in the past 30 days prior to first dose.
- Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to first dose.
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 60 days or 5 half-lives of that drug prior to first dose, whichever is longer.
- History of alcoholism or drug abuse within 2 years prior to check-in or 3 months before Screening, or excessive alcohol consumption (regular alcohol intake > 21 units per week for male participants and > 14 units of alcohol per week for female participants) (1 unit is equal to approximately 0.5 pint [200 milliliters (mL)] of beer, 1 small glass [100 mL] of wine, or 1 measure [25 mL] of spirits).
- Poor peripheral venous access. Note: Other inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Randomized, Two-Period Crossover Study to Assess the Relative Bioavailability of Brensocatib Pediatric Oral Solution to Oral Tablets Following Single Oral Doses in Healthy Subjects
The primary purpose of this study is to determine the relative bioavailability of brensocatib between the pediatric oral solution and oral tablets in healthy participants.
- Conditions
- Healthy Participants
- Being tested
- Brensocatib Oral Solution, Brensocatib Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brensocatib Oral SolutionDrug
Also called INS1007
Brensocatib solution
Brensocatib Oral TabletDrug
Also called INS1007
Brensocatib tablet
| Study group | Role | What they receive |
|---|---|---|
| Brensocatib Treatment Sequence AB | Experimental | Participants will receive a single dose of the pediatric oral brensocatib solution (Treatment A) on Day 1 followed by a washout period of 9 days. On Day 10, participants will receive a single dose of the oral brensocatib tablet (Treatment B). Receives: Drug: Brensocatib Oral Solution; Drug: Brensocatib Oral Tablet |
| Brensocatib Treatment Sequence BA | Experimental | Participants will receive a single dose of the oral brensocatib tablet (Treatment B) on Day 1 followed by a washout period of 9 days. On Day 10, participants will receive a single dose of the pediatric oral brensocatib solution (Treatment A). Receives: Drug: Brensocatib Oral Solution; Drug: Brensocatib Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Bioavailability Between Brensocatib Pediatric Oral Solution and Oral Tablets for Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC∞) of Brensocatib in Plasma
Pharmacokinetics of brensocatib following a single dose in healthy participants will be assessed.
Measured: Pre-dose and at multiple timepoints post-dose on Days 1 and 10
Secondary outcomes (2)
Number of Participants who Experienced at Least one Adverse Event (AE)
Measured: Up to Day 23
Concentration of Brensocatib in Plasma
Pharmacokinetics of brensocatib following a single administration of different oral formulations in healthy participants will be assessed.
Measured: Pre-dose and at multiple timepoints post-dose on Days 1 and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start30 Apr 2024
- Primary completion24 May 2024
- Study completion24 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Crossover
- Masking
- None (open label)
- 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
- NCT06344728
- Sponsor's protocol ID
- INS1007-110
- Acronym
- INS1007
- Status last verified
- Jun 2024
- First submitted
- 27 Mar 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Randomized, Two-Period Crossover Study to Assess the Relative Bioavailability of Brensocatib Pediatric Oral Solution to Oral Tablets Following Single Oral Doses in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06344728
- Acronym / sponsor ID
- INS1007 / INS1007-110
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Insmed IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 24 May 2024 (actual)
- Study completion
- 24 May 2024 (actual)
- First posted
- 3 Apr 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 relative bioavailability of brensocatib between the pediatric oral solution and oral tablets in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brensocatib Treatment Sequence AB | Experimental | Drug: Brensocatib Oral Solution, Drug: Brensocatib Oral TabletParticipants will receive a single dose of the pediatric oral brensocatib solution (Treatment A) on Day 1 followed by a washout period of 9 days. On Day 10, participants will receive a single dose of the oral brensocatib tablet (Treatment B). |
| Brensocatib Treatment Sequence BA | Experimental | Drug: Brensocatib Oral Solution, Drug: Brensocatib Oral TabletParticipants will receive a single dose of the oral brensocatib tablet (Treatment B) on Day 1 followed by a washout period of 9 days. On Day 10, participants will receive a single dose of the pediatric oral brensocatib solution (Treatment A). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body mass index between 18.0 and 32.0 kilogram per square meter (kg/m^2), and a body weight of ≥ 50 kilogram (kg) at Screening.
- Female participants of childbearing potential must have a negative urine or serum pregnancy test at Screening and Day -1 and agree to contraceptive requirements.
- To be a non-smoker and has not used chewing tobacco for at least 3 months prior to screening.
- Women must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or using highly effective contraception from Screening to at least 30 days after discharge.
- Male participants must be on a stable method of contraception starting at Screening and continuing to at least 30 days after discharge.
Key exclusion criteria (6 listed)
- History of stomach, gall bladder, or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
- Administration of a coronavirus disease 2019 vaccine in the past 30 days prior to first dose.
- Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to first dose.
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 60 days or 5 half-lives of that drug prior to first dose, whichever is longer.
- History of alcoholism or drug abuse within 2 years prior to check-in or 3 months before Screening, or excessive alcohol consumption (regular alcohol intake > 21 units per week for male participants and > 14 units of alcohol per week for female participants) (1 unit is equal to approximately 0.5 pint [200 milliliters (mL)] of beer, 1 small glass [100 mL] of wine, or 1 measure [25 mL] of spirits).
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 |
|---|---|---|
| Brensocatib Oral SolutionAlso: INS1007Brensocatib solution | Drug | Brensocatib Treatment Sequence AB, Brensocatib Treatment Sequence BA |
| Brensocatib Oral TabletAlso: INS1007Brensocatib tablet | Drug | Brensocatib Treatment Sequence AB, Brensocatib Treatment Sequence BA |
Primary outcome
Relative Bioavailability Between Brensocatib Pediatric Oral Solution and Oral Tablets for Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC∞) of Brensocatib in Plasma
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 and 10
Pharmacokinetics of brensocatib following a single dose in healthy participants will be assessed.
2 secondary outcomes
Number of Participants who Experienced at Least one Adverse Event (AE)
Time frame: Up to Day 23
Concentration of Brensocatib in Plasma
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 and 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 13 Jun 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 Brensocatib Oral Solution and Brensocatib Oral Tablet in people with Healthy Participants, 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 6 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 13 Jun 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?
Relative Bioavailability Between Brensocatib Pediatric Oral Solution and Oral Tablets for Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC∞) of Brensocatib in Plasma (time frame: Pre-dose and at multiple timepoints post-dose on Days 1 and 10). 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 13 Jun 2024.