GDC-6599 for Chronic Cough

Recruiting at 10 trial locations

Overseen By Reference Study ID Number: GA43590, https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Genentech, Inc.

Must be taking: ICS therapy

Must not be taking: ACE inhibitors, Opioids

Disqualifiers: Pregnancy, Hepatic impairment, Pneumonia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called GDC-6599 to see if it can help people with chronic coughs that haven't been cured by other treatments. The study will look at how well the drug works, its safety, and how it behaves in the body.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as ACE inhibitors, opioids, pregabalin, gabapentin, amitriptyline, nortriptyline, and cough suppressants, before and during the study. If you are on these medications, you will need to stop them for a specific period before joining the trial.

How does the drug GDC-6599 differ from other treatments for chronic cough?

GDC-6599 is a novel treatment for chronic cough, which is often treated with centrally acting opioids like morphine and codeine or peripherally acting antitussives like moguisteine. Unlike these existing treatments, GDC-6599 may offer a new mechanism of action or improved efficacy, especially for patients who do not respond to current options. ^{1 2 3 4 5}

Research Team

Clinical Trials

Principal Investigator

Genetech

Eligibility Criteria

Adults with chronic cough and a physician's diagnosis of asthma or COPD, who are not current smokers and have used bronchodilator medication for at least 12 weeks. They must not be pregnant, breastfeeding, or planning to become pregnant soon. Participants should not have had respiratory infections recently or been treated with certain medications like opioids for cough within the last two weeks.

Inclusion Criteria

Your lung function test shows that you can breathe out at least 60% of the air you're supposed to.

I have had colorectal cancer, asthma, COPD, or upper cervical cancer for over a year.

I have never smoked or quit smoking more than 6 months ago, with less than 20 pack-years of history.

Exclusion Criteria

I am not pregnant, breastfeeding, nor planning to become pregnant soon.

I haven't taken strong CYP3A affecting drugs in the last month.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive GDC-6599 or placebo for 14 days

2 weeks

3 visits (in-person)

Washout

A 14-day washout period between treatment periods

2 weeks

Treatment Period 2

Participants receive the alternate treatment (GDC-6599 or placebo) for 14 days

2 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• GDC-6599
• GDC-6599-matching placebo

Trial Overview The trial is testing GDC-6599 against a placebo to see if it helps people with chronic cough. It's a Phase IIa study where patients will randomly receive either the drug or placebo in different periods without knowing which one they're taking (double-blind). The effects on coughing, safety, how the body processes the drug (pharmacokinetics), and its biological actions (pharmacodynamics) are being studied.

Participant Groups

Group I: Part B: Chronic Refractory Cough with Chronic Obstructive Pulmonary Disease with Chronic Bronchitis Experimental Treatment 3 Interventions

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.

Group II: Part B: Chronic Refractory Cough with Chronic Obstructive Pulmonary Disease Experimental Treatment 3 Interventions

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.

Group III: Part A: Unexplained Chronic Cough Experimental Treatment 3 Interventions

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

Group IV: Part A: CRC Asthma non-atopic Experimental Treatment 3 Interventions

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

Group V: Part A: CRC Asthma atopic Experimental Treatment 3 Interventions

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

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

[Chronic cough]. [2013]

2. Australia pubmed.ncbi.nlm.nih.gov

The patient with chronic cough. [2004]

3. China pubmed.ncbi.nlm.nih.gov

Drug-induced chronic cough and the possible mechanism of action. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Distribution of chronic cough phenotypes in the general population: A cross-sectional analysis of the LEAD cohort in Austria. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Currently available cough suppressants for chronic cough. [2021]