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This study evaluates the safety, tolerability, and activity of inhaled GDC-6988 in participants with muco-obstructive disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GDC-6988 | Experimental | Participants in Cohort 1 will receive low-dose GDC-6988, twice a day (BID) on Day 1, followed by high-dose, BID on Day 2. Participants in Cohort 2 will receive low-dose, followed by high-dose GDC-6988, BID for 14 days. Participants in Cohorts 3 and 4 will receive low-dose GDC-6988, BID for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-6988 | Drug | GDC-6988 will be administered using a dry powder inhalation (DPI) device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs), with Severity Assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Toxicity Grading Scale | The AEs will be graded according to the DAIDS table for grading the severity. The severity level is graded from Grade 1 (mild) to 4 (Potentially Life-Threatening). | From baseline up to 6 weeks |
| Percentage of Participants With Spirometry Abnormalities | From baseline up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Percentage of Participants With Spirometry Abnormalities Without and With Albuterol Pretreatment | Spirometric abnormalities related to forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and maximal (peak) inspiratory flow rate, and flow-volume loops will be reported. | From baseline up to 6 weeks |
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Inclusion Criteria:
Additional Inclusion Criteria for Participants in Part B
Additional Inclusion Criteria for Participants With Non-cystic Fibrosis Bronchiectasis (NCFB) (Cohort 1, Cohort 2, and Cohort 3):
- Diagnosis of bronchiectasis on the basis of prior chest computed tomography (CT), involving at least 2 lobes, with at least one lobe of involvement in the right lung as assessed by the investigator
Additional Inclusion Criteria for Participants With Chronic Obstructive Pulmonary Disease (COPD) (Cohort 1, Cohort 2, and Cohort 4):
Exclusion Criteria:
Additional Exclusion Criteria for Participants in Part B -More than 2 chest CTs or other procedures known to expose the lungs to greater than 100 millisievert (mSv) within 12 months prior to screening
Additional Exclusion Criteria for Participants With NCFB (Cohort 1, Cohort 2, and Cohort 3)
Additional Exclusion Criteria for Participants with NCFB in Cohort 3
- Diagnosis of COPD that, in the investigator's judgment, is the primary driver of the individual's respiratory disease (e.g., primary COPD with incidental bronchiectasis findings)
Additional Exclusion Criteria for Participants With COPD (Cohort 1, Cohort 2, and Cohort 4):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: GB45429 https://forpatients.roche.com/ | Contact | 888-662-6728 (U.S. Only) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35233 | United States | |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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| Plasma Concentration of GDC-6988 at Specified Timepoints |
Other relevant pharmacokinetic (PK) parameters may be assessed. |
| Part A: Day 1 and Day 2, Part B: Day 1, Day 8 and Day 15 |
| Part B: Change From Baseline in Sputum Percent Solids at Day 8 and Day 14 | Baseline, at Day 8 and at Day 14 |
| Part B: Change From Baseline in Whole-lung Mucociliary Clearance (MCC) Scintigraphy at Day 8 | Baseline and at Day 8 |
| Part B: Change From Baseline in Sputum Percent Solids at Day 15 | Baseline and at Day 15 |
| Part B: Change From Baseline in Whole-lung MCC Scintigraphy at Day 15 | Baseline and at Day 15 |
| Accel Research Site - Achieve - Birmingham - ERN - PPDS |
| Withdrawn |
| Vestavia Hills |
| Alabama |
| 35216-1927 |
| United States |
| Stanford Center for Excellence in Pulmonary Biology | Recruiting | Palo Alto | California | 94304 | United States |
| University of Kansas Medical Center-Kansas City-3901 Rainbow Blvd | Recruiting | Kansas City | Kansas | 66160 8500 | United States |
| University of North Carolina Clinical Research Center | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
| UPMC Montefiore Hospital | Recruiting | Pittsburgh | Pennsylvania | 15213 3236 | United States |
| TTS Research | Completed | Boerne | Texas | 78006 | United States |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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