Healthy VolunteersPhase 1NCT05826574
A Study to Assess Pharmacokinetics (PK) of Brensocatib Alone and With Multiple Doses of Rifampin or Esomeprozole in Healthy Participants
A Phase 1 study testing Brensocatib, Rifampin and Esomeprazole 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 assess the effects of rifampin on the PK of brensocatib in Part 1 of the study and to assess the effects of esomeprazole on the PK of brensocatib in Part 2 of the study. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Brensocatib, Rifampin and Esomeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2023to 16 Jul 2023
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participants defined by no significant other conditions as in the protocol.
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, immunological, oncologic, or psychiatric disorder, as determined by the investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator (or designee).
- 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, Fixed Sequence Study to Assess the Pharmacokinetics of Brensocatib When Administered Alone and With Multiple Doses of Rifampin (CYP3A Inducer) or Esomeprazole (Proton Pump Inhibitor) in Healthy Subjects
The primary purpose of this study is to assess the effects of rifampin on the PK of brensocatib in Part 1 of the study and to assess the effects of esomeprazole on the PK of brensocatib in Part 2 of the study.
- Conditions
- Healthy Volunteers
- Being tested
- Brensocatib, Rifampin, Esomeprazole
- Keywords
- Brensocatib, INS1007
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrensocatibDrug
Also called INS1007
Oral tablets.
RifampinDrug
Oral capsules.
EsomeprazoleDrug
Oral capsules.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Period 1: Brensocatib | Experimental | Period 1: Participants will receive a single oral dose of brensocatib on Day 1 in Part 1 of the study. Receives: Drug: Brensocatib |
| Part 1: Period 2: Brensocatib + Rifampin | Experimental | Period 2: Participants will receive rifampin 600 mg once daily (QD), orally, on Days 8 to 23 along with a single oral dose of brensocatib prior to the rifampin administration on Day 17 in Part 1 of the study. Receives: Drug: Brensocatib; Drug: Rifampin |
| Part 2: Period 1: Brensocatib | Experimental | Period 1: Participants will receive a single oral dose of brensocatib on Day 1 in Part 2 of the study. Receives: Drug: Brensocatib |
| Part 2: Period 2: Brensocatib + Esomeprazole | Experimental | Period 2: Participants will receive esomeprazole 40 mg QD, orally, on Days 8 to 12 along with a single oral dose of brensocatib prior to the esomeprazole administration on Day 12 in Part 2 of the study. Receives: Drug: Brensocatib; Drug: Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts 1 and 2: Area Under the Concentration-time (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 to 7, 17 (Part 1), and Days 1 to 7, 12 to 18 (Part 2)
Secondary outcomes (1)
Parts 1 and 2: Number of Participants Who Experienced at Least One Adverse Event (AE)
Safety and tolerability of brensocatib when administered alone and in combination with rifampin/esomeprazole will be determined in healthy participants.
Measured: Up to Day 31 (Part 1) and up to Day 26 (Part 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start10 May 2023
- Primary completion16 Jul 2023
- Study completion16 Jul 2023
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT05826574
- Sponsor's protocol ID
- INS1007-106
- Status last verified
- Aug 2023
- First submitted
- 12 Apr 2023
- Last updated
- 21 Aug 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 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Fixed Sequence Study to Assess the Pharmacokinetics of Brensocatib When Administered Alone and With Multiple Doses of Rifampin (CYP3A Inducer) or Esomeprazole (Proton Pump Inhibitor) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05826574
- Acronym / sponsor ID
- INS1007-106
- Conditions
- Healthy Volunteers
- Keywords
- Brensocatib, INS1007
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Insmed IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 10 May 2023 (actual)
- Primary completion
- 16 Jul 2023 (actual)
- Study completion
- 16 Jul 2023 (actual)
- First posted
- 24 Apr 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 assess the effects of rifampin on the PK of brensocatib in Part 1 of the study and to assess the effects of esomeprazole on the PK of brensocatib in Part 2 of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: Period 1: Brensocatib | Experimental | Drug: BrensocatibPeriod 1: Participants will receive a single oral dose of brensocatib on Day 1 in Part 1 of the study. |
| Part 1: Period 2: Brensocatib + Rifampin | Experimental | Drug: Brensocatib, Drug: RifampinPeriod 2: Participants will receive rifampin 600 mg once daily (QD), orally, on Days 8 to 23 along with a single oral dose of brensocatib prior to the rifampin administration on Day 17 in Part 1 of the study. |
| Part 2: Period 1: Brensocatib | Experimental | Drug: BrensocatibPeriod 1: Participants will receive a single oral dose of brensocatib on Day 1 in Part 2 of the study. |
| Part 2: Period 2: Brensocatib + Esomeprazole | Experimental | Drug: Brensocatib, Drug: EsomeprazolePeriod 2: Participants will receive esomeprazole 40 mg QD, orally, on Days 8 to 12 along with a single oral dose of brensocatib prior to the esomeprazole administration on Day 12 in Part 2 of the study. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy participants defined by no significant other conditions as in the protocol.
Key exclusion criteria (3 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, immunological, oncologic, or psychiatric disorder, as determined by the investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator (or designee).
- Note: Other inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| BrensocatibAlso: INS1007Oral tablets. | Drug | Part 1: Period 1: Brensocatib, Part 1: Period 2: Brensocatib + Rifampin, Part 2: Period 1: Brensocatib, Part 2: Period 2: Brensocatib + Esomeprazole |
| RifampinOral capsules. | Drug | Part 1: Period 2: Brensocatib + Rifampin |
| EsomeprazoleOral capsules. | Drug | Part 2: Period 2: Brensocatib + Esomeprazole |
Primary outcome
Parts 1 and 2: Area Under the Concentration-time (AUC) of Brensocatib in Plasma
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 7, 17 (Part 1), and Days 1 to 7, 12 to 18 (Part 2)
Pharmacokinetics of brensocatib following a single dose in healthy participants will be assessed.
1 secondary outcome
Parts 1 and 2: Number of Participants Who Experienced at Least One Adverse Event (AE)
Time frame: Up to Day 31 (Part 1) and up to Day 26 (Part 2)
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 21 Aug 2023.
- 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, Rifampin and Esomeprazole 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 3 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 Aug 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 1 and 2: Area Under the Concentration-time (AUC) of Brensocatib in Plasma (time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 7, 17 (Part 1), and Days 1 to 7, 12 to 18 (Part 2)). 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 21 Aug 2023.