Healthy VolunteersPhase 1NCT05652257
A Study of the Absorption, Metabolism, and Excretion of [14C]-Brensocatib Following a Single Oral Administration in Healthy Male Participants
A Phase 1 study testing [14C]-brensocatib in people with Healthy Volunteers, run by Insmed Incorporated at 1 site in United States.
Trial summary
The primary purpose of the study is to determine the mass balance of total radioactivity and the routes of elimination by quantifying the urinary and fecal excretion of radioactivity following a single oral administration of [14C]-brensocatib, to characterize the pharmacokinetics (PK) of brensocatib in plasma and… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [14C]-brensocatib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2021to 14 Sep 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index between 18.0 and 32.0 kilograms per square meter (kg/m^2), inclusive, at screening.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in as assessed by the investigator (or designee).
Who cannot join
- Positive hepatitis panel and/or positive human immunodeficiency virus test. Results consistent with previous vaccination to Hepatitis B are not exclusionary.
- Administration of a coronavirus disease 2019 (COVID-19) vaccine in the past 14 days prior to dosing.
- Poor peripheral venous access.
- Have previously completed or withdrawn from this study or any other study investigating brensocatib, and have previously received brensocatib. Known allergy to brensocatib or any of the excipients used in the formulation.
- Exposure to significant diagnostic or therapeutic radiation (e.g., serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
- Participated in more than 3 radiolabeled drug studies in the last 12 months (previous study to be at least 4 months prior to check-in to the study site where exposures are known to the investigator or 6 months prior to check-in to the study site for a radiolabeled drug study where exposures are not known to the investigator).
- 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 Study of the Absorption, Metabolism, and Excretion of [14C]-Brensocatib Following a Single Oral Administration in Healthy Male Subjects
The primary purpose of the study is to determine the mass balance of total radioactivity and the routes of elimination by quantifying the urinary and fecal excretion of radioactivity following a single oral administration of [14C]-brensocatib, to characterize the pharmacokinetics (PK) of brensocatib in plasma and urine, PK of total radioactivity in plasma, whole blood, urine and to determine the blood-to-plasma ratios of total radioactivity.
- Conditions
- Healthy Volunteers
- Being tested
- [14C]-brensocatib
- Keywords
- [14C]-brensocatib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-brensocatibDrug
Oral solution.
| Study group | Role | What they receive |
|---|---|---|
| [14C]-brensocatib | Experimental | Healthy participants will receive single oral dose of [14C]-brensocatib on Day 1 under fasted conditions. Receives: Drug: [14C]-brensocatib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration Time Curve (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 Day 1 up to maximum Day 14
AUC∞ Plasma Brensocatib/Plasma Total Radioactivity Ratio Calculated as AUC∞ of Plasma Brensocatib Relative to AUC∞ of Plasma Total Radioactivity
Measured: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
AUC∞ Blood/Plasma Total Radioactivity Ratio Calculated as AUC∞ of Whole Blood Total Radioactivity to AUC∞ of Plasma Total Radioactivity
Measured: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
Amount Excreted in Urine (Aeu) of Brensocatib
Measured: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
Total Radioactivity Expressed as Amount of [14C]-brensocatib Excreted in Urine
Measured: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
Total Radioactivity Expressed as Amount of [14C]-brensocatib Excreted in Feces (Aef)
Measured: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
Secondary outcomes (2)
AUC of Brensocatib Metabolites in Plasma
Pharmacokinetics of the metabolites following a single dose of brensocatib in healthy participants will be assessed.
Measured: Pre-dose and at multiple timepoints post-dose on Days 1 to 9
Number of Participants Who Experienced at Least one Adverse Event (AE)
Safety and tolerability of a single dose of brensocatib will be determined in healthy participants.
Measured: Up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start13 Aug 2021
- Primary completion14 Sep 2021
- Study completion14 Sep 2021
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 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
- NCT05652257
- Sponsor's protocol ID
- INS1007-103
- Status last verified
- Mar 2023
- First submitted
- 7 Dec 2022
- Last updated
- 23 Mar 2023
- 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 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Brensocatib Following a Single Oral Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05652257
- Acronym / sponsor ID
- INS1007-103
- Conditions
- Healthy Volunteers
- Keywords
- [14C]-brensocatib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Insmed IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 14 Sep 2021 (actual)
- Study completion
- 14 Sep 2021 (actual)
- First posted
- 15 Dec 2022 (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 the study is to determine the mass balance of total radioactivity and the routes of elimination by quantifying the urinary and fecal excretion of radioactivity following a single oral administration of [14C]-brensocatib, to characterize the pharmacokinetics (PK) of brensocatib in plasma and urine, PK of total radioactivity in plasma, whole blood, urine and to determine the blood-to-plasma ratios of total radioactivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-brensocatib | Experimental | Drug: [14C]-brensocatibHealthy participants will receive single oral dose of [14C]-brensocatib on Day 1 under fasted conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index between 18.0 and 32.0 kilograms per square meter (kg/m^2), inclusive, at screening.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in as assessed by the investigator (or designee).
Key exclusion criteria (7 listed)
- Positive hepatitis panel and/or positive human immunodeficiency virus test. Results consistent with previous vaccination to Hepatitis B are not exclusionary.
- Administration of a coronavirus disease 2019 (COVID-19) vaccine in the past 14 days prior to dosing.
- Poor peripheral venous access.
- Have previously completed or withdrawn from this study or any other study investigating brensocatib, and have previously received brensocatib. Known allergy to brensocatib or any of the excipients used in the formulation.
- Exposure to significant diagnostic or therapeutic radiation (e.g., serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
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 |
|---|---|---|
| [14C]-brensocatibOral solution. | Drug | [14C]-brensocatib |
Primary outcome
Area Under the Concentration Time Curve (AUC) of Brensocatib in Plasma
Time frame: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
Pharmacokinetics of brensocatib following a single dose in healthy participants will be assessed.
AUC∞ Plasma Brensocatib/Plasma Total Radioactivity Ratio Calculated as AUC∞ of Plasma Brensocatib Relative to AUC∞ of Plasma Total Radioactivity
Time frame: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
AUC∞ Blood/Plasma Total Radioactivity Ratio Calculated as AUC∞ of Whole Blood Total Radioactivity to AUC∞ of Plasma Total Radioactivity
Time frame: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
Amount Excreted in Urine (Aeu) of Brensocatib
Time frame: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
Total Radioactivity Expressed as Amount of [14C]-brensocatib Excreted in Urine
Time frame: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
Total Radioactivity Expressed as Amount of [14C]-brensocatib Excreted in Feces (Aef)
Time frame: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14
2 secondary outcomes
AUC of Brensocatib Metabolites in Plasma
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 9
Number of Participants Who Experienced at Least one Adverse Event (AE)
Time frame: Up to Day 14
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 23 Mar 2023.
- Individual participant dataSharing planned: No
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Screening Protocol
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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 [14C]-brensocatib 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 2 inclusion and 7 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 23 Mar 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?
Area Under the Concentration Time Curve (AUC) of Brensocatib in Plasma (time frame: Pre-dose and at multiple timepoints post-dose on Day 1 up to maximum Day 14). The study lists 6 primary outcomes in all. 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 23 Mar 2023.