A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamic Effects Of GDC-6599 In Patients With Chronic Cough
A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamic Effects Of GDC-6599 In Patients With Chronic Cough
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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date: January 13, 2023
Estimated Primary Completion Date: September 15, 2024
Estimated Study Completion Date: September 15, 2024
Arm:
- Experimental: Part A: CRC Asthma atopic
- Experimental: Part A: CRC Asthma non-atopic
- Experimental: Part A: Unexplained Chronic Cough
- Experimental: Part B: Chronic Refractory Cough with Chronic Obstructive Pulmonary Disease
- Experimental: Part B: Chronic Refractory Cough with Chronic Obstructive Pulmonary Disease with Chronic Bronchitis
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 80 |
| Actual Study start date | 13 January 2023 |
| Estimated Study Completion Date | 15 September 2024 |