A Study to Test the Safety and Effects of Inhaled GDC-6988 in Participants With Muco-obstructive Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenentech, Inc.
About this trial
This study evaluates the safety, tolerability, and activity of inhaled GDC-6988 in participants with muco-obstructive disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
GDC-6988
DrugGDC-6988 will be administered using a dry powder inhalation (DPI) device.
Treatment groups
128 Participants
are divided into 1 treatment groupGroup A: GDC-6988Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 weeks2
Percentage of Participants With Spirometry Abnormalities
Time frame
From baseline up to 6 weeksSecondary outcomes
1
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 weeks2
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 153
Part B: Change From Baseline in Sputum Percent Solids at Day 8 and Day 14
Time frame
Baseline, at Day 8 and at Day 144
Part B: Change From Baseline in Whole-lung Mucociliary Clearance (MCC) Scintigraphy at Day 8
Time frame
Baseline and at Day 8Sponsors and contacts
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Source ClinicalTrials.gov