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

COMPLETEDPHASE2

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

A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamic Effects Of GDC-6599 In Patients With Chronic Cough

NCT05660850•Genentech, Inc.

View on ClinicalTrials.gov

Summary

This Phase IIa, multicenter, randomized, double-blind, placebo-controlled, crossover study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamic (PD) effects of GDC-6599 compared with placebo in patients with a history of chronic cough.

Detailed Description

The main study (Part A) enrolled participants with chronic refractory cough (CRC) with asthma with/without atopy as well as participants with unexplained chronic cough (UCC); the substudy (Part B) enrolled participants with chronic obstructive pulmonary disease (COPD) with/without chronic bronchitis (CB). 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).

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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
+6 more criteria

Exclusion Criteria

•Pregnant or breastfeeding, or intention of becoming pregnant during the study or within 28 days after the final dose of GDC-6599
•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
+4 more criteria

Locations (18)

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

Key Dates

Start Date

March 22, 2023

Primary Completion Date

October 20, 2024

Completion Date

October 20, 2024

Last Updated

December 16, 2025

Enrollment

ACTUAL participants

Conditions

Chronic Refractory Cough (CRC) With Non-atopic AsthmaCRC With Atopic AsthmaUnexplained Chronic CoughCRC With Chronic Obstructive Pulmonary DiseaseCRC With Chronic Obstructive Pulmonary Disease With Chronic Bronchitis

Interventions

GDC-6599

DRUG

GDC-6599-matching placebo

OTHER

Mannitol

DIAGNOSTIC_TEST

ATP Level and Cough Sensitivity to ATP in Subjects With Refractory/Unexplained Chronic Cough

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Refractory/Unexplained Chronic Cough

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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