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A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis

Sponsor
Insmed Incorporated (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05090904
Collaborator
(none)
48
Enrollment
24
Locations
5
Arms
16.5
Anticipated Duration (Months)
2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objective of the study is to evaluate the pharmacokinetics of brensocatib in participants with cystic fibrosis following once daily oral administration of study drug and to evaluate the safety of brensocatib compared to placebo in participants with cystic fibrosis (CF) over the 4-week treatment period.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2a, Single-Blind, Placebo-Controlled, Parallel-Group Study to Assess Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis
Actual Study Start Date :
Nov 30, 2021
Anticipated Primary Completion Date :
Apr 17, 2023
Anticipated Study Completion Date :
Apr 17, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Brensocatib 10 mg

Participants will be administered brensocatib at a dose of 10 mg once per day for 28 days. Half of the participants in the arm will have previously received and will continue to be administered cystic fibrosis transmembrane conductance regulators (CFTRs) during the study. The other half of participants in the arm will have not previously received and will not be administered CFTRs during the study.

Drug: Brensocatib
Oral tablet
Other Names:
  • INS1007

    		•
    Experimental: Brensocatib 25 mg

    Participants will be administered brensocatib at a dose of 25 mg once per day for 28 days. Half of the participants in the arm will have previously received and will continue to be administered CFTRs during the study. The other half of participants in the arm will have not previously received and will not be administered CFTRs during the study.

    Drug: Brensocatib
    Oral tablet
    Other Names:
  • INS1007

    		•
    Experimental: Brensocatib 40 mg

    Participants will be administered brensocatib at a dose of 40 mg once per day for 28 days. Half of the participants in the arm will have previously received and will continue to be administered CFTRs during the study. The other half of participants in the arm will have not previously received and will not be administered CFTRs during the study.

    Drug: Brensocatib
    Oral tablet
    Other Names:
  • INS1007

    		•
    Experimental: Brensocatib 65 mg

    Following review of safety and pharmacokinetic data by the safety review committee, an additional cohort of participants may be administered brensocatib at a dose of 65 mg once per day for 28 days. Half of the participants in the arm will have previously received and will continue to be administered CFTRs during the study. The other half of participants in the arm will have not previously received and will not be administered CFTRs during the study.

    Drug: Brensocatib
    Oral tablet
    Other Names:
  • INS1007

    		•
    Placebo Comparator: Placebo

    Participants will be administered a placebo matching brensocatib once per day for 28 days. Half of the participants in the arm will have previously received and will continue to be administered CFTRs during the study. The other half of participants in the arm will have not previously received and will not be administered CFTRs during the study.

    Drug: Placebo
    Oral tablet

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Plasma Concentration (Cmax) of Brensocatib [Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, 24 and 168 hours postdose]

    2. Time to Maximum Plasma Concentration (tmax) of Brensocatib [Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, 24 and 168 hours postdose]

    3. Area Under the Concentration-time Curve from Time 0 to 24 Hours Post-dose (AUC0-24) of Brensocatib [Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, 24 hours postdose]

    4. Elimination Half-life (t1/2) of Brensocatib [Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, 24 and 168 hours postdose]

    5. Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE) [Day 1 to Day 56]

    Secondary Outcome Measures

    1. Dose-normalized Maximum Plasma Concentration (Cmax) of Brensocatib [Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, 24 and 168 hours postdose]

    2. Dose-normalized Area Under the Concentration-time Curve from Time 0 to 24 Hours Post-dose (AUC0-24) of Brensocatib [Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, 24 hours postdose]

    3. Dose-normalized Area Under the Concentration-time Curve from Time 0 to the Time of Last Measurable Concentration (AUClast) of Brensocatib [Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, 24 and 168 hours postdose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Participants must be ≥18 years of age at the time of signing the informed consent.

    • Male or female participants with a confirmed diagnosis of CF related lung disease:

    1. Stable CF treatment for at least 30 days and willing to remain on a stable regimen throughout the treatment period.

    • Has a body mass index ≥18 kg/m^2.

    • Male and female participants must use contraceptives that are consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

    1. Male participants, who are not sterile, with female partners of childbearing potential must be using effective contraception from Day 1 to at least 90 days after the last dose.

    2. Women must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or using highly effective contraception methods (ie, methods that alone or in combination achieve <1% unintended pregnancy rates per year when used consistently and correctly) from Day 1 to at least 90 days after the last dose.

    • Male participants with pregnant or nonpregnant women of childbearing potential partners must use a condom.
    Exclusion Criteria:

    • Severe or unstable CF, per Investigator's judgement. .

    • Currently being treated for allergic bronchopulmonary aspergillosis or nontuberculous mycobacteria or tuberculosis.

    • Active and current infection by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

    • History of malignancy in the past 5 years, except completely treated in situ carcinoma of the cervix and completely treated non-metastatic squamous or basal cell carcinoma of the skin.

    • Established diagnosis of hepatitis B viral infection or positive for hepatitis B surface antigen (HBsAg) at Screening.

    • History of human immunodeficiency virus (HIV) infection.

    • Acute upper or lower respiratory tract infection, pulmonary exacerbation, or changes in therapy (including intravenous and oral antibiotics) for pulmonary disease within 4 weeks prior to Day 1 (administration of the first dose of study drug). Participants meeting this criterion could be rescreened 4 weeks after resolution of symptoms.

    • History of solid organ or hematological transplantation.

    • Currently being treated for periodontal disease.

    • Received any live attenuated vaccine within 4 weeks prior Screening.

    • Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within 90 days prior to Screening.

    • Known history of hypersensitivity to brensocatib or any of its excipients.

    • Use of any immunomodulatory agents within 4 weeks before the Screening Visit is prohibited during the study through end of study (including, but not limited to: bortezomib, ixazomib, thalidomide, cyclophosphamide, mycophenolate, Janus kinase inhibitors, interferon gamma (IFN-γ], and azathioprine).

    • Continuous use of high-dose non-steroidal anti-inflammatory drugs (NSAIDs) is prohibited during the study through end of study.

    • History of alcohol, medication, or illicit drug abuse.

    • Current smoker, as defined by Centers for Disease Control and Prevention: An adult who has smoked 100 cigarettes in his or her lifetime and who currently smokes cigarettes.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 USA021 Birmingham Alabama United States 35233-1711
    2 USA012 La Jolla California United States 92037-1300
    3 USA013 Sacramento California United States 95817-2201
    4 USA024 Santa Barbara California United States 93102
    5 USA001 Gainesville Florida United States 32610-0001
    6 USA005 Orlando Florida United States 32803-5443
    7 USA020 Atlanta Georgia United States 30322-1014
    8 USA016 Augusta Georgia United States 30912-0004
    9 USA025 Glenview Illinois United States 60025-7645
    10 USA011 Boston Massachusetts United States 02115-5724
    11 USA023 Ann Arbor Michigan United States 48109
    12 USA002 Saint Louis Missouri United States 63101
    13 USA022 New York New York United States 10032-3720
    14 USA008 Cleveland Ohio United States 44106-1716
    15 USA006 Cleveland Ohio United States 44195-0001
    16 USA007 Columbus Ohio United States 43205-2664
    17 USA018 Portland Oregon United States 97239-3011
    18 USA014 Pittsburgh Pennsylvania United States 15224-1334
    19 USA009 Charleston South Carolina United States 29425-8900
    20 USA017 Nashville Tennessee United States 37232-0028
    21 USA004 Dallas Texas United States 75390-7208
    22 USA010 Houston Texas United States 77030
    23 USA003 Tyler Texas United States 75708
    24 USA015 Salt Lake City Utah United States 84108-1287

    Sponsors and Collaborators

    • Insmed Incorporated

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Insmed Incorporated
    ClinicalTrials.gov Identifier:
    NCT05090904
    Other Study ID Numbers:
    • INS1007-211
    First Posted:
    Oct 25, 2021
    Last Update Posted:
    Aug 1, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Insmed Incorporated
    Cystic Fibrosis
    Brensocatib
    Additional relevant MeSH terms:
    Cystic Fibrosis
    Fibrosis

    Study Results

    No Results Posted as of Aug 1, 2022