GDC-6988
DrugGDC-6988 will be administered using a dry powder inhalation (DPI) device.
Other names: RO7506811
NCT Number: NCT06603246
This study evaluates the safety, tolerability, and activity of inhaled GDC-6988 in participants with muco-obstructive disease.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
University of Alabama at Birmingham, Birmingham, Alabama, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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):
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
Additional Exclusion Criteria for Participants With COPD (Cohort 1, Cohort 2, and Cohort 4):
GDC-6988 will be administered using a dry powder inhalation (DPI) device.
Other names: RO7506811
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).
Time frame: From baseline up to 6 weeks
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.
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.
Time frame: Baseline, at Day 8 and at Day 14
Time frame: Baseline and at Day 8
Time frame: Baseline and at Day 15
Time frame: Baseline and at Day 15
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
888-662-6728 (U.S. Only)
Genentech, Inc.
Industry
A Phase Ic, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, and Activity of Inhaled GDC-6988 in Patients With Muco-obstructive Disease
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.
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