Evaluation of S-600918 in Adults With Refractory Chronic Cough

• Status: Completed
• Trial end date: 2020-12-28
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to determine the optimal dose of S-600918 in patients with refractory chronic cough by evaluating the change from baseline in 24-hour cough frequency (coughs per hour) with S-600918 compared with placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shionogi

Criteria

Key Inclusion Criteria:

• Having refractory chronic cough (including unexplained chronic cough) for at least 1 year.

• If female and of childbearing potential, agreement to use one of the allowed contraceptive methods.

• Capable of giving signed informed consent.

Key Exclusion Criteria:

• Currently smokes or uses potentially irritating inhalational agents (eg, e-cigarettes, smokeless cigarettes, vaping); stopped smoking or using potentially irritating inhalational agents within the last year; or has a smoking history of 20 pack-years or more.

• Has chronic obstructive pulmonary disease or uncontrolled asthma.

• Has a clinically unstable medical condition.

• History of or ongoing significant psychiatric disorder.

• History of respiratory tract infection or significant change in lung function or a pulmonary condition in the last 4 weeks.

• History of malignancy in the last 5 years.

• History of severe drug allergy.

• History of alcohol or drug abuse in the last year or currently uses any form of marijuana or illicit drugs.

• Has a clinically significant finding on a chest x-ray or chest computed tomography (CT) scan in the last year.

• Has systolic blood pressure > 160 mm Hg or diastolic blood pressure > 90 mm Hg.

• Received S-600918 previously.

• Received an investigational drug in the last 3 months.

• Received an angiotensin converting enzyme (ACE) inhibitor in the last 3 months or requires such treatment.

• Has a positive serologic test for human immunodeficiency virus (HIV) antigen or antibody, hepatitis B virus surface antigen, or hepatitis C virus ribonucleic acid (RNA).

• If female, pregnant or trying to become pregnant or breastfeeding.