Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06603246

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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 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):

  • 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 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 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 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)

  • 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
  • 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 pipes.

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):

  • COPD exacerbation within 28 days prior to screening or that has not returned to baseline
  • Asthma/COPD overlap syndrome

Treatment and study plan

GDC-6988

Drug

GDC-6988 will be administered using a dry powder inhalation (DPI) device.

Other names: RO7506811

Primary outcomes

  1. Percentage of Participants With Adverse Events (AEs), with Severity Assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Toxicity Grading Scale

    Time frame: From baseline up to 6 weeks

    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).

  2. Percentage of Participants With Spirometry Abnormalities

    Time frame: From baseline up to 6 weeks

Secondary outcomes

  1. Part A: Percentage of Participants With Spirometry Abnormalities Without and With Albuterol Pretreatment

    Time frame: From baseline up to 6 weeks

    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.

  2. Plasma Concentration of GDC-6988 at Specified Timepoints

    Time frame: Part A: Day 1 and Day 2, Part B: Day 1, Day 8 and Day 15

    Other relevant pharmacokinetic (PK) parameters may be assessed.

  3. Part B: Change From Baseline in Sputum Percent Solids at Day 8 and Day 14

    Time frame: Baseline, at Day 8 and at Day 14

  4. Part B: Change From Baseline in Whole-lung Mucociliary Clearance (MCC) Scintigraphy at Day 8

    Time frame: Baseline and at Day 8

  5. Part B: Change From Baseline in Sputum Percent Solids at Day 15

    Time frame: Baseline and at Day 15

  6. Part B: Change From Baseline in Whole-lung MCC Scintigraphy at Day 15

    Time frame: Baseline and at Day 15

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number: GB45429 https://forpatients.roche.com/

CONTACT

[email protected]

888-662-6728 (U.S. Only)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Phase Ic, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, and Activity of Inhaled GDC-6988 in Patients With Muco-obstructive Disease

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.