GSK-206764

Study Sponsor: GSK

Study Title

An open-label study in healthy male subjects, to determine the excretion balance and pharmacokinetics of [14C]-GSK2269557, administered as a single intravenous microtracer (concomitant with an inhaled non-radiolabelled dose) and a single oral dose

Medicine or Vaccine (generic name)

nemiralisib

Sponsor Identification Number

206764

Trial Registry Identification Number(#'s)

NCT03315559 2017-002347-16

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=206764

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

http://clinicaltrials.gov/show/NCT03315559

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=/2017-002347-16

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. This study is available in CDISC format.

Date Added to this Site

January 2020