GSK-202031

Study Sponsor: GSK

Study Title

A double-blind (sponsor unblind), randomized, placebo-controlled, single and repeat escalating dose study to investigate the safety, tolerability, and pharmacokinetics of CCI15106 capsules for inhalation in healthy subjects and patients with moderate chronic obstructive pulmonary disease (COPD)

Medicine or Vaccine (generic name)

ribavirin

Sponsor Identification Number

202031

Trial Registry Identification Number(#'s)

NCT03243760 2015-003960-35

Medical Condition

Pulmonary Disease, Chronic Obstructive

Phase

Phase 1

Link to study details on the GSK Clinical Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=202031

Link to study details on ClinicalTrials.gov (if available)

http://clinicaltrials.gov/show/NCT03243760

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=/2015-003960-35

Datasets and Documents Available for this Study

Raw dataset	Annotated case report form	Dataset specifications	Protocol with any amendments
Analysis-ready dataset	Reporting and analysis plan	Clinical study report	Ready to Share

Additional information about the data and documents available for this study

An annotated case report form is not available for this study. A blank case report form will be provided. The data for this study is available in CDISC format.

Date Added to this Site

May 2020