A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamic Effects Of GDC-6599 In Patients With Chronic Cough
NCT ID: NCT05660850
Last Updated: 2025-12-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
49 participants
INTERVENTIONAL
2023-03-22
2024-10-20
Brief Summary
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Detailed Description
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The main objective of the study was was to evaluate the efficacy of GDC-6599, as compared with placebo, in participants with CRC with asthma or UCC (i.e. across all participants in main study - Part A, regardless of the disease background).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Part A: CRC Asthma atopic
Patients with CRC atopic asthma will be randomized in a 1:1 ratio to receive GDC-6599 or placebo for 14 days during the first study period (Treatment Period 1, Study Visits 2-4). Following a 14-day washout period, patients will cross over to the second study period (Treatment Period 2, Study Visits 5-7) and will receive the alternate treatment (GDC-6599 or placebo) for 14 days starting at Study Visit 5
GDC-6599
GDC-6599 will be administered Days 1- 14 and on Days 29-42 as film-coated tablets
GDC-6599-matching placebo
GDC-6599-matching placebo will be administered Days 1- 14 and on Days 29- 42. as film-coated tablets
Mannitol
Mannitol challenge tests will be performed during screening and at least 2.5 hours following study drug administration at Study Visits 2, 4, 5 and 7
Part A: CRC Asthma non-atopic
Patients with CRC non-atopic asthma will be randomized in a 1:1 ratio to receive GDC-6599 or placebo for 14 days during the first study period (Treatment Period 1, Study Visits 2-4). Following a 14-day washout period, patients will cross over to the second study period (Treatment Period 2, Study Visits 5-7) and will receive the alternate treatment (GDC-6599 or placebo) for 14 days starting at Study Visit 5
GDC-6599
GDC-6599 will be administered Days 1- 14 and on Days 29-42 as film-coated tablets
GDC-6599-matching placebo
GDC-6599-matching placebo will be administered Days 1- 14 and on Days 29- 42. as film-coated tablets
Mannitol
Mannitol challenge tests will be performed during screening and at least 2.5 hours following study drug administration at Study Visits 2, 4, 5 and 7
Part A: Unexplained Chronic Cough
Patients with Unexplained Chronic Cough will be randomized in a 1:1 ratio to receive GDC-6599 or placebo for 14 days during the first study period (Treatment Period 1, Study Visits 2-4). Following a 14-day washout period, patients will cross over to the second study period (Treatment Period 2, Study Visits 5-7) and will receive the alternate treatment (GDC-6599 or placebo) for 14 days starting at Study Visit 5
GDC-6599
GDC-6599 will be administered Days 1- 14 and on Days 29-42 as film-coated tablets
GDC-6599-matching placebo
GDC-6599-matching placebo will be administered Days 1- 14 and on Days 29- 42. as film-coated tablets
Mannitol
Mannitol challenge tests will be performed during screening and at least 2.5 hours following study drug administration at Study Visits 2, 4, 5 and 7
Part B: Chronic Refractory Cough with Chronic Obstructive Pulmonary Disease
Patients with Chronic Obstructive Pulmonary Disease will be randomized in a 1:1 ratio to receive GDC-6599 or placebo for 14 days during the first study period (Treatment Period 1, Study Visits 2-4). Following a 14-day washout period, patients will cross over to the second study period (Treatment Period 2, Study Visits 5-7) and will receive the alternate treatment (GDC-6599 or placebo) for 14 days starting at Study Visit 5.
GDC-6599
GDC-6599 will be administered Days 1- 14 and on Days 29-42 as film-coated tablets
GDC-6599-matching placebo
GDC-6599-matching placebo will be administered Days 1- 14 and on Days 29- 42. as film-coated tablets
Mannitol
Mannitol challenge tests will be performed during screening and at least 2.5 hours following study drug administration at Study Visits 2, 4, 5 and 7
Part B: Chronic Refractory Cough with Chronic Obstructive Pulmonary Disease with Chronic Bronchitis
Patients with Chronic Obstructive Pulmonary Disease with Chronic Bronchitis will be randomized in a 1:1 ratio to receive GDC-6599 or placebo for 14 days during the first study period (Treatment Period 1, Study Visits 2-4). Following a 14-day washout period, patients will cross over to the second study period (Treatment Period 2, Study Visits 5-7) and will receive the alternate treatment (GDC-6599 or placebo) for 14 days starting at Study Visit 5.
GDC-6599
GDC-6599 will be administered Days 1- 14 and on Days 29-42 as film-coated tablets
GDC-6599-matching placebo
GDC-6599-matching placebo will be administered Days 1- 14 and on Days 29- 42. as film-coated tablets
Mannitol
Mannitol challenge tests will be performed during screening and at least 2.5 hours following study drug administration at Study Visits 2, 4, 5 and 7
Interventions
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GDC-6599
GDC-6599 will be administered Days 1- 14 and on Days 29-42 as film-coated tablets
GDC-6599-matching placebo
GDC-6599-matching placebo will be administered Days 1- 14 and on Days 29- 42. as film-coated tablets
Mannitol
Mannitol challenge tests will be performed during screening and at least 2.5 hours following study drug administration at Study Visits 2, 4, 5 and 7
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chest X-ray or computed tomography (CT) scan thorax within 5 years prior to screening visit that confirms the absence of any clinically significant abnormality contributing to the chronic cough in the opinion of the investigator
* Cough severity VAS score ≥ 40 at screening visit
* Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 60% of predicted at screening"
* Mannitol CDR ≥ 12 coughs/100 mg determined at screening visit mannitol challenge test
* For women of childbearing potential: agreement to remain abstinent or use contraception For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm
* Physician diagnosis of asthma for ≥ 12 months based upon GINA STEP 2-5
* Stable treatment with ICS therapy (GINA STEP 2) or ICS therapy and at least one additional controller (GINA STEP 3- 5) for ≥ 3 months
* Patients with atopic asthma (n = 20), based upon historic record of positive test for atopy (if available), or confirmed at screening by positive fluorescence enzyme immunoassay for specific IgE against at least one of the following five perennial aeroallergens: animal (cat dander, dog dander, cockroach), dust mite (Dermatophagoides farinae, Dermatophagoides pteronyssinus), and mold mix
* Patients with non-atopic asthma (n = 20), based upon historic record of negative test for atopy (if available), or confirmed at screening by negative ImmunoCAP test result for all five perennial aeroallergens: animal (cat dander, dog dander, cockroach), dust mite (Dermatophagoides farinae, Dermatophagoides pteronyssinus), and mold mix, and relevant local allergens, and no history of symptoms suggesting atopy
* Never or former smoker (≥ 6 months prior to screening) with \< 20 pack-years or equivalent history
* Diagnosis of COPD GOLD I-II ± CB
* Stable background treatment consisting of a bronchodilator medication and or stable ICS therapy for ≥ 12 weeks prior to screening visit
* Former smoker with ≥ 10 pack-years or equivalent history within 6 months of screening
* Post-bronchodilator FEV1/ forced vital capacity (FVC) ratio ≤ 0.70 at screening
* Chest X-ray or CT scan within 6 months prior to screening visit or during the screening period (prior to randomization \[Study Visit 2\]), that confirms the absence of clinically significant lung disease besides COPD
Exclusion Criteria
* History of diagnosed bleeding diathesis or easy bruising or bleeding
* Post-bronchodilator FEV1/ FVC ratio \< 0.60 at screening visit (patients with CRC asthma and UCC only: Part A)
* History of significant hepatic impairment
* History of aspiration or recurrent pneumonia
* Respiratory infection (including upper respiratory infection) within 8 weeks prior to screening
* Treatment with any strong inhibitor or inducer of CYP3A within 28 days or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study drug
* Treatment with angiotensin-converting enzyme (ACE) inhibitor within 12 weeks prior to screening (Study Visit 1) through completion of the study
* Treatment with opioids (including codeine), pregabalin, gabapentin, amitriptyline, or nortriptyline for the treatment of cough within 2 weeks prior to screening (Study Visit 1) through completion of the study
* Treatment with cough suppressant medication within 2 weeks prior to screening (Study Visit 1) through completion of the study
* Known coronavirus 2019 (COVID-19) infection, persistent symptoms of known prior COVID-19 infection, and/or known positive COVID-19 test within at least 8 weeks prior to screening and randomization
* Clinical laboratory value outside the reference range for the test laboratory at screening
* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
* History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix or non-melanoma skin carcinoma
18 Years
80 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genetech
Locations
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Southern California Institute For Respiratory
Los Angeles, California, United States
California Medical Research Associates, Inc.
Northridge, California, United States
Pioneer Clinical Studies
Coral Gables, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
Clinical Research Associates Of Central Pa , Llc
DuBois, Pennsylvania, United States
ADAC Research PA
Greenville, South Carolina, United States
Pharmaceutical Research & Consulting, Inc.
Dallas, Texas, United States
Bellingham Asthma, Allergy & Immunology
Bellingham, Washington, United States
TrialsWest Pty Ltd
Spearwood, Western Australia, Australia
McMaster University Medical Centre
Hamilton, Ontario, Canada
Diex Recherche - Québec - HyperCore - PPDS
Québec, , Canada
Castle Hill Hospital
Cottingham, North Humberside, United Kingdom
Belfast City Hospital
Belfast, , United Kingdom
West Walk Surgery
Bristol, , United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Glenfield Hospital
Leicester, , United Kingdom
Kings College Hospital
London, , United Kingdom
Queen Anne Street Medical Centre
London, , United Kingdom
Countries
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References
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Brown I, Tran T, Funwie A, Patel S, Dawson K, McKenzie M. Sexual orientation and gender identity data: An observational study assessing the feasibility of SOGI collection in clinical research and patient assistance programs. PLoS One. 2025 Oct 22;20(10):e0332805. doi: 10.1371/journal.pone.0332805. eCollection 2025.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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GA43590
Identifier Type: -
Identifier Source: org_study_id