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Be Part of Research - Trial Details - 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

Completed

Open to: ALL

Age: 18.0 - 80.0

Medical Conditions

Bronchitis
Bronchitis, Chronic
Asthma
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Cough
Chronic Cough


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Mar 2023 Oct 2024

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : GDC-6599 will be administered Days 1- 14 and on Days 29-42 as film-coated tablets

Intervention Arm Group : Part A: CRC Asthma atopic;Part A: CRC Asthma non-atopic;Part A: Unexplained Chronic Cough;Part B: Chronic Refractory Cough with Chronic Obstructive Pulmonary Disease;Part B: Chronic Refractory Cough with Chronic Obstructive Pulmonary Disease with Chronic Bronchitis;

Intervention Type : OTHER
Intervention Description : GDC-6599-matching placebo will be administered Days 1- 14 and on Days 29- 42. as film-coated tablets

Intervention Arm Group : Part A: CRC Asthma atopic;Part A: CRC Asthma non-atopic;Part A: Unexplained Chronic Cough;Part B: Chronic Refractory Cough with Chronic Obstructive Pulmonary Disease;Part B: Chronic Refractory Cough with Chronic Obstructive Pulmonary Disease with Chronic Bronchitis;

Intervention Type : DIAGNOSTIC_TEST
Intervention Description : 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

Intervention Arm Group : Part A: CRC Asthma atopic;Part A: CRC Asthma non-atopic;Part A: Unexplained Chronic Cough;Part B: Chronic Refractory Cough with Chronic Obstructive Pulmonary Disease;Part B: Chronic Refractory Cough with Chronic Obstructive Pulmonary Disease with Chronic Bronchitis;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Glenfield Hospital
    Leicester
    LE3 9QP
  • Belfast City Hospital
    Belfast
    BT9 7AB
  • West Walk Surgery
    Bristol
    BS37 4AX
  • Kings College Hospital
    London
    SW9 8RR
  • Queen Anne Street Medical Centre
    London
    W1T 6AH
  • Hull York Medical School Centre for Cardiovascular and Metabolic Research
    Kingston-upon-Hull
    HU6 7RX
  • Royal Infirmary of Edinburgh
    Edinburgh
    EH16 4SA


The study is sponsored by Genentech, Inc.




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Read full details for Trial ID: NCT05660850
Last updated 28 November 2024

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