A Phase IIa study to evaluate the efficacy and safety of GDC-6599 in patients with chronic cough
Research type
Research Study
Full title
A Phase IIa, multicenter, randomized, double-blind, placebo-controlled, crossover study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamic effects of GDC-6599 in patients with chronic cough
IRAS ID
1005994
Contact name
Eric Olson
Contact email
Sponsor organisation
Genetech, Inc.
Eudract number
2022-003459-32
Research summary
This study will test a drug called GDC-6599, which is being developed for the treatment of chronic cough & asthma. The purpose of this study is to compare the effects of GDC-6599 versus placebo on patients with chronic cough. Patients with refractory chronic cough (RCC) with asthma, unexplained chronic cough (UCC), or chronic obstructive pulmonary disease (COPD) with chronic refractory cough (CRC) are being asked to participate. Participants will get either GDC-6599 or placebo treatment for a certain period of time & then switch to the opposite treatment for a certain time.
Patients will be enrolled in either Part A (Main study) or Part B (Sub study) portion of the study depending on their disease background. Patients with RCC with atopic or non-atopic asthma or UCC will be eligible to participate in Part A portion of the study. Patients with COPD with or without chronic bronchitis and CRC will be eligible to participate in Part B.
Patients enrolled in either Part A or Part B will receive GDC-6599 or placebo, given as a pill twice a day for 14 days during the initial treatment period (Treatment Period 1); and following a 2-week washout period (when no drug treatment is administered), will receive the alternate treatment (GDC-6599 or placebo), given as a pill every 14 days during the second treatment period (Treatment Period 2).
There will be eight study visits lasting 2-4 hours each. The study will consist of a screening period of approximately 14 days and will be followed by a 14-day treatment period. After a two-week washout, patients will begin another 14-day treatment period during which time the opposite treatment will be administered. Following another two-week washout period, patients will progress to a 28-day safety follow-up.REC name
London - Chelsea Research Ethics Committee
REC reference
23/LO/0048
Date of REC Opinion
17 Jul 2023
REC opinion
Further Information Favourable Opinion