A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamic Effects Of GDC-6599 In Patients With Chronic Cough

Inclusion Criteria

• •Previous diagnosis of CRC, despite optimized treatment for asthma or COPD, or UCC for at least 1 year
• •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