This study evaluates the safety, tolerability, and activity of inhaled GDC-6988 in participants with muco-obstructive disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
128
GDC-6988 will be administered using a dry powder inhalation (DPI) device.
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGAccel Research Site - Achieve - Birmingham - ERN - PPDS
Vestavia Hills, Alabama, United States
WITHDRAWNStanford Center for Excellence in Pulmonary Biology
Palo Alto, California, United States
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).
Time frame: From baseline up to 6 weeks
Percentage of Participants With Spirometry Abnormalities
Time frame: From baseline up to 6 weeks
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.
Time frame: From baseline up to 6 weeks
Plasma Concentration of GDC-6988 at Specified Timepoints
Other relevant pharmacokinetic (PK) parameters may be assessed.
Time frame: 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
Time frame: Baseline, at Day 8 and at Day 14
Part B: Change From Baseline in Whole-lung Mucociliary Clearance (MCC) Scintigraphy at Day 8
Time frame: Baseline and at Day 8
Part B: Change From Baseline in Sputum Percent Solids at Day 15
Time frame: Baseline and at Day 15
Part B: Change From Baseline in Whole-lung MCC Scintigraphy at Day 15
Reference Study ID Number: GB45429 https://forpatients.roche.com/
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University of Kansas Medical Center-Kansas City-3901 Rainbow Blvd
Kansas City, Kansas, United States
RECRUITINGUniversity of North Carolina Clinical Research Center
Chapel Hill, North Carolina, United States
RECRUITINGUPMC Montefiore Hospital
Pittsburgh, Pennsylvania, United States
RECRUITINGTTS Research
Boerne, Texas, United States
COMPLETEDTime frame: Baseline and at Day 15