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A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamic Effects Of GDC-6599 In Patients With Chronic Cough

NCT05660850 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2025-12-16

Study results available
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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.

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

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

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Genetech

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-22
Primary Completion
2024-10-20
Completion
2024-10-20
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05660850 on ClinicalTrials.gov