Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05090904
Recruitment Status : Recruiting
First Posted : October 25, 2021
Last Update Posted : June 23, 2022
Sponsor:
Information provided by (Responsible Party):
Insmed Incorporated

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
Cystic Fibrosis Drug: Brensocatib Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 30, 2021
Estimated Primary Completion Date : April 17, 2023
Estimated Study Completion Date : April 17, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

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 Name: 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 Name: 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 Name: 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 Name: 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




Primary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) of Brensocatib [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Day 1 to Day 56 ]

Secondary Outcome Measures :
  1. Dose-normalized Maximum Plasma Concentration (Cmax) of Brensocatib [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    a. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05090904


Contacts
Layout table for location contacts
Contact: Insmed Medical Information 1-844-446-7633 medicalinformation@insmed.com

Locations
Show Show 22 study locations
Sponsors and Collaborators
Insmed Incorporated
Layout table for additonal information
Responsible Party: Insmed Incorporated
ClinicalTrials.gov Identifier: NCT05090904    
Other Study ID Numbers: INS1007-211
First Posted: October 25, 2021    Key Record Dates
Last Update Posted: June 23, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases