Safety and PK Study of GDC-6988 with and without Salbutamol pre-treatment (QSC207610)
Research type
Research Study
Full title
A PHASE Ib, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE-CENTER STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF MULTIPLE ASCENDING DOSES OF GDC-6988 WITH AND WITHOUT ALBUTEROL PRETREATMENT IN HEALTHY ADULT SUBJECTS
IRAS ID
1005551
Contact name
Eric Olson
Contact email
Sponsor organisation
Genentech, Inc.
Eudract number
2022-000455-36
ISRCTN Number
ISRCTN30841680
Research summary
The Sponsor is developing the test medicine, GDC-6988, for the potential treatment of cystic fibrosis (CF). CF is a genetic disorder, in which the lungs and digestive system get clogged with mucus and can be dangerous and ultimately lead to death. There are treatments available to manage CF, but there is currently no known cure.
GDC-6988 increases the activity of the chloride channels in your airways, which help regulate how wet mucus in your airways is. These channels do not work correctly for people with CF, and this leads to a build-up of thick mucus that more readily sticks to the walls of the airways, which can lead to blockages that cause lung damage and respiratory infections, such as pneumonia.
This single part healthy volunteer study will try to evaluate the safety of GDC-6988 and compare how GDC-6988 behaves when the dose is increased, and when taken alone or alongside Salbutamol, which is an approved medicine that relaxes the muscles of the airways into the lungs, making it easier to breathe.
This study will take place at 1 non-NHS site, enrolling up to 50 male and female volunteers aged between 18 and 55 who will be divided in up to 5 cohorts of 10 volunteers. Cohorts 4 and 5 are optional.
Volunteers will receive an inhaled dose of up to 42.0 mg of GDC-6988 or placebo (dummy medicine) twice a day from Day 1 to Day 14. Volunteers will also receive an inhaled dose of 200 µg Salbutamol twice a day from Day 8 to Day 14, and this will be given approximately 15 minutes before they receive GDC-6988. A Smart Dry Powder Inhaler will be used to administer the doses of GDC-6988 or placebo and Salbutamol.
Volunteers will be discharged on Day 15 and will return to the clinic on Day 18 and Day 42 for follow-up visits.
Volunteer’s blood and urine will be taken throughout the study for analysis of the test medicine and for their safety.
Volunteers are expected to be involved in this study for approximately 11 weeks from screening to the final follow-up visit.REC name
London - Riverside Research Ethics Committee
REC reference
22/LO/0500
Date of REC Opinion
17 Aug 2022
REC opinion
Further Information Favourable Opinion