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Tests treatment safety and results for Non-cystic Fibrosis Bronchiectasis
Official title A Study to Test the Safety and Effects of Inhaled GDC-6988 in Participants With Muco-obstructive Disease
ClinicalTrials.gov ID: NCT06603246
What this study is testing
What is GDC-6988?
GDC-6988 is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for non-cystic fibrosis bronchiectasis.
Also referred to as RO7506811.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study evaluates the safety, tolerability, and activity of inhaled GDC-6988 in participants with muco-obstructive disease.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 disease for ≥ 28 days prior to screening and through to initiation of study treatment Additional for Participants in Part B
- Chronic sputum production of ≥1 teaspoon per day as reported in the sputum volume item
You likely can't join if
- 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 milliliter (mL) within 3 months prior to screening
- Known immunodeficiency that, in the investigator's judgment, is clinically significant and places the individual at a substantially elevated risk for...
See the full eligibility 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 for Participants in Part B
- Chronic sputum production of ≥1 teaspoon per day as reported in the sputum volume item
- Ability to produce a sputum sample that is suitable for central laboratory determination of mucus percent solids and sialic acid concentration exploratory biomarker research, and biomarker assay development
- Availability of a representative blood sample for exploratory biomarker research and biomarker assay development Additional for Participants With Non-cystic Fibrosis Bronchiectasis (NCFB) (Cohort 1, Cohort 2, and Cohort...
- 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
- 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 milliliter (mL) within 3 months prior to screening
- Known immunodeficiency that, in the investigator's judgment, is clinically significant and places the individual at a substantially elevated risk for opportunistic infections.
- 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...
- 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 in Part B -More than 2 chest CTs or other...
- 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)...
- Diagnosis of asthma, that in the investigator's judgment, is the primary driver of the individual's respiratory disease (e.g., primary asthma with incidental bronchiectasis findings)
- 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...
- COPD exacerbation within 28 days prior to screening or that has not returned to baseline
- Asthma/COPD overlap syndrome
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Vestavia Hills, Alabama, United States
- Palo Alto, California, United States
- Kansas City, Kansas, United States
- Chapel Hill, North Carolina, United States
- Pittsburgh, Pennsylvania, United States
- Boerne, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Vestavia Hills, Alabama, United States; Palo Alto, California, United States; Kansas City, Kansas, United States; Chapel Hill, North Carolina, United States; Pittsburgh, Pennsylvania, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.