Trials / Completed
CompletedNCT05660850
A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamic Effects Of GDC-6599 In Patients With Chronic Cough
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- Genentech, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This Phase IIa, multicenter, randomized, double-blind, placebo-controlled, crossover study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamic (PD) effects of GDC-6599 compared with placebo in patients with a history of chronic cough.
Detailed description
The main study (Part A) enrolled participants with chronic refractory cough (CRC) with asthma with/without atopy as well as participants with unexplained chronic cough (UCC); the substudy (Part B) enrolled participants with chronic obstructive pulmonary disease (COPD) with/without chronic bronchitis (CB). The main objective of the study was was to evaluate the efficacy of GDC-6599, as compared with placebo, in participants with CRC with asthma or UCC (i.e. across all participants in main study - Part A, regardless of the disease background).
Conditions
- Chronic Refractory Cough (CRC) With Non-atopic Asthma
- CRC With Atopic Asthma
- Unexplained Chronic Cough
- CRC With Chronic Obstructive Pulmonary Disease
- CRC With Chronic Obstructive Pulmonary Disease With Chronic Bronchitis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GDC-6599 | GDC-6599 will be administered Days 1- 14 and on Days 29-42 as film-coated tablets |
| OTHER | GDC-6599-matching placebo | GDC-6599-matching placebo will be administered Days 1- 14 and on Days 29- 42. as film-coated tablets |
| DIAGNOSTIC_TEST | Mannitol | Mannitol challenge tests will be performed during screening and at least 2.5 hours following study drug administration at Study Visits 2, 4, 5 and 7 |
Timeline
- Start date
- 2023-03-22
- Primary completion
- 2024-10-20
- Completion
- 2024-10-20
- First posted
- 2022-12-21
- Last updated
- 2025-12-16
- Results posted
- 2025-12-16
Locations
18 sites across 4 countries: United States, Australia, Canada, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05660850. Inclusion in this directory is not an endorsement.