University of Kansas Medical Center

A Study to Test the Safety and Effects of Inhaled GDC-6988 in Participants With Muco-Obstructive Disease

Purpose

This study evaluates the safety, tolerability, and activity of inhaled GDC-6988 in participants with muco-obstructive disease.

Conditions

Non Cystic Fibrosis Bronchiectasis
Chronic Obstructive Pulmonary Disease

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Percent predicted FEV1 ≥ 40% by spirometry during screening - Ability to demonstrate correct use of the Smart DPI at screening, in the investigator's judgment - On a stable treatment regimen for muco-obstructive diseases for ≥ 28 days prior to initiation of study treatment and willingness to remain on the stable treatment regimen through completion of study - Stable disease for ≥ 28 days prior to screening and through to initiation of study treatment 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 and Cohort 4): - COPD defined as post-bronchodilator FEV1/FVC ratio of <0.7 - Chronic bronchitis, with a definition including chronic cough and excessive sputum production for more than 3 months per year for at least 2 years prior to screening - Former smoker with a minimum of 10 pack-year history (e.g., 20 cigarettes/day for 10 years) or non-smoker with at least one documented COPD risk factor

Exclusion Criteria

Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the timeframe in which contraception is required - Known significant bronchodilator response of >10% predicted change in FEV1 or FVC, in the investigator's judgment - Use of any prohibited medications - Acute respiratory infection within 28 days of screening - Significant hemoptysis greater than 60 mL within 3 months prior to screening - Known immunodeficiency including, but not limited to, human immunodeficiency virus (HIV) infection with CD4+ T cell count <200 cells/mm^3 or an acquired immunodeficiency syndrome (AIDS)-defining condition 6 months prior to screening - Known substance abuse, in the investigator's judgment, within 12 months prior to screening - Poor peripheral venous access - Receipt of blood products within 120 days prior to screening - Any medical condition or abnormal clinical laboratory finding that, in the investigator's judgment, would preclude the individual's safe participation in and completion of the study or could affect the interpretation of the results - History of thoracic or metastatic malignancy within 5 years prior to screening - Known history of a clinically significant abnormal electrocardiogram (ECG), or presence of an abnormal ECG that is deemed clinically significant by the investigator - QT interval corrected through use of Fridericia's formula (QTcF) >450 milliseconds (ms) for males or >470 ms for females Additional Exclusion Criteria for Participants with NCFB (Cohort 1, Cohort 2, and Cohort 3) - Bronchiectasis primarily due to cystic fibrosis, primary ciliary dyskinesia, non-tuberculous mycobacterial infection, chronic aspiration, or predominantly traction bronchiectasis due to interstitial lung disease (ILD), in the investigator's judgment - Primary diagnosis of COPD or asthma, in the investigator's judgment - NCFB exacerbation within 28 days prior to screening or that has not returned to baseline - Current smoker: Current smoking is defined as any use of inhaled tobacco products or inhaled marijuana within 3 months prior to screening, through use of cigarettes, cigars, electronic cigarettes, vaporizing devices, or pipes. Additional Exclusion Criteria for Participants with COPD (Cohort 1 and Cohort 4): - COPD exacerbation within 28 days prior to screening or that has not returned to baseline - Asthma/COPD overlap syndrome

Study Design

Phase: Phase 1
Study Type: Interventional
Allocation: N/A
Intervention Model: Sequential Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental GDC-6988	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.	Drug: GDC-6988 GDC-6988 will be administered using a dry powder inhalation

Recruiting Locations

University of Kansas Medical Center-Kansas City-3901 Rainbow Blvd
Kansas City, Kansas 66160 8500

More Details

Status: Recruiting
Sponsor: Genentech, Inc.

Study Contact

Reference Study ID Number: GB45429 https://forpatients.roche.com/
888-662-6728 (U.S. Only)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.