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Healthy VolunteerPhase 1NCT05355935

A Study to Investigate the Effects of Brensocatib on QT Interval in Healthy Participants

A Phase 1 study testing Brensocatib and Moxifloxacin in people with Healthy Volunteer, run by Insmed Incorporated at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study has 2 Parts: The primary purpose of Part 1 is to determine the supratherapeutic dose of brensocatib to be used in Part 2 of the study. The primary purpose of Part 2 is to assess brensocatib's potential for prolonging the QT interval. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteer
What is being tested?
Brensocatib and Moxifloxacin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteUnited States
Study dates
27 Apr 2022to 7 Oct 2022
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 (BMI) between 18.0 and 32.0 kilogram per square metre (kg/m^2), inclusive, and a total body weight greater than or equal to 50 kilograms (kg)
  • Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception
  • Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions
  • Able to swallow tablets

Who cannot join

  • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee)
  • History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
  • QTcF interval >430 ms for males and >440 ms for females or QRS >120 ms
  • A history of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia, or family history of long QT syndrome)
  • Positive serology test results for hepatitis B panel and hepatitis C antibody and/or reactive human immunodeficiency virus 1/2 test
  • Administration of a coronavirus disease 2019 (COVID-19) vaccine in the past 14 days prior to dosing
Show all 20Show fewer
  • Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing, unless deemed acceptable by the investigator (or designee)
  • Use or intend to use any prescription medications/products within 14 days prior to dosing, unless deemed acceptable by the investigator (or designee)
  • Use or intend to use slow-release medications/products considered to still be active within 14 days prior to check-in, unless deemed acceptable by the investigator (or designee)
  • Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to check-in, unless deemed acceptable by the investigator (or designee)
  • Use or intend to use any medications that may increase QT interval within 14 days prior to check-in
  • Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days prior to dosing
  • Have previously completed or withdrawn from this study or any other study investigating brensocatib, and have previously received brensocatib
  • Alcohol consumption of >14 units per week for males and >7 units for females. One unit of alcohol equals 12 ounce (oz) (360 milliliter [mL]) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine
  • Consumption of caffeine-containing products within 48 hours prior to check-in, unless deemed acceptable by the investigator (or designee)
  • History of chemical abuse, illicit substance, or marijuana use within 1 year prior to check-in
  • Use of tobacco- or nicotine-containing products within 3 months prior to check-in
  • Receipt of blood products within 2 months prior to check-in
  • Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening
  • Poor peripheral venous access

Trial locations and contacts

1 site in 1 country.

United States1 site

  • USA001

    Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: A Two-part, Phase I, Double-blind, Placebo- and Positive-controlled Crossover Study to Investigate the Effects of Brensocatib on QT Interval in Healthy Subjects

The study has 2 Parts: The primary purpose of Part 1 is to determine the supratherapeutic dose of brensocatib to be used in Part 2 of the study.

The primary purpose of Part 2 is to assess brensocatib's potential for prolonging the QT interval.

Being tested
Brensocatib, Moxifloxacin, Placebo
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 tablet.

  • MoxifloxacinDrug

    Oral tablet.

  • PlaceboDrug

    Oral tablet.

Study groups in NCT05355935
Study groupRoleWhat they receive
Part 1: Treatment Dose 1ExperimentalParticipants (in a 3:1 ratio) will receive a single oral dose of brensocatib Dose 1 or placebo, once on Day 1.
Receives: Drug: Brensocatib; Drug: Placebo
Part 1: Treatment Dose 2ExperimentalParticipants (in a 3:1 ratio) will receive a single oral dose of brensocatib Dose 2 or placebo, once on Day 1.
Receives: Drug: Brensocatib; Drug: Placebo
Part 2ExperimentalParticipants will be randomized to 1 of 4 treatment sequences (ABCD, BDAC, CADB, DCBA).
Receives: Drug: Brensocatib; Drug: Moxifloxacin; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of Participants who Experienced at least one Treatment-Emergent Adverse Event (TEAE) as Assessed by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)

    Measured: Up to Day 7

  2. Part 2: Placebo- and Baseline-Corrected QTcF (ΔΔQTcF)

    Measured: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period

Secondary outcomes (10)

  1. Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Brensocatib

    Measured: Part 1: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part 2: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period

  2. Parts 1 and 2: Time to Maximum Observed Plasma Concentration (Tmax) of Brensocatib

    Measured: Part 1: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part 2: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period

  3. Parts 1 and 2: Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUCtlast) of Brensocatib

    Measured: Part 1: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part 2: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period

  4. Parts 1 and 2: AUC From Time Zero Extrapolated to Infinity (AUC∞) of Brensocatib

    Measured: Part 1: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part 2: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period

  5. Parts 1 and 2: Elimination Half-Life (t1/2) of Brensocatib

    Measured: Part 1: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part 2: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period

  6. Parts 1 and 2: Total Clearance of Brensocatib Following Extravascular Administration (CL/F)

    Measured: Part 1: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part 2: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period

  7. Parts 1 and 2: Volume of Distribution of Brensocatib Following Extravascular Administration (Vz/F)

    Measured: Part 1: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part 2: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period

  8. Parts 2: Change From Baseline in QTcF (ΔQTcF) Interval

    Measured: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period

  9. Part 2: Number of Participants With Categorical Outliers for ECG Parameters: HR, PR, QRS, and QTcF

    Measured: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period

  10. Part 2: Number of Participants who Experienced at least one TEAE

    Measured: 7 days after the last dose (up to 35 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2022
  2. Study start27 Apr 2022
  3. Primary completion7 Oct 2022
  4. Study completion7 Oct 2022

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05355935
Sponsor's protocol ID
INS1007-104
Status last verified
Mar 2023
First submitted
26 Apr 2022
Last updated
27 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Brensocatib and Moxifloxacin in people with Healthy Volunteer, 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 20 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 27 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?

Part 1: Number of Participants who Experienced at least one Treatment-Emergent Adverse Event (TEAE) as Assessed by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) (time frame: Up to Day 7). The study lists 2 primary outcomes in all. 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 NCT05355935.

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 27 Mar 2023.

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