ID
33385
Description
Study ID: 107806 Clinical Study ID: RA3107806 Study Title: An open label study to determine the safety, tolerability, excretion balance and pharmacokinetics of Losmapimod, administered as a single dose of an oral solution to healthy adult male subjects Patient Level Data: Clinicaltrials.gov Identifier: NCT00599612 https://clinicaltrials.gov/ct2/show/NCT00599612 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: losmapimod Trade Name: losmapimod Study Indication: Pulmonary Disease, Chronic Obstructive The study consists of a screening, study visit and follow-up. The protocol identifier for all: RA3107806 This document contains Study conclusion, Investigator Comment Log, Investigator's signature. It has to be filled in for the end of study.
Link
https://clinicaltrials.gov/ct2/show/NCT00599612
Keywords
Versions (2)
- 12/7/18 12/7/18 -
- 12/11/18 12/11/18 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
December 7, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612
Study conclusion, Investigator Comment Log, Investigator's signature
Description
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C1549507
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C0422727
Description
Subject's withdraw
Data type
text
Alias
- UMLS CUI [1]
- C2349954
Description
If you tick 1: Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate. To 6 and 7: Only tick if none of the other primary reasons are appropriate
Data type
integer
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0566251
Description
Investigator discretion, specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0022423
- UMLS CUI [2,1]
- C2349954
- UMLS CUI [2,2]
- C0566251
Description
Withdrew consent , specification
Data type
text
Alias
- UMLS CUI [1]
- C1707492
- UMLS CUI [2,1]
- C2349954
- UMLS CUI [2,2]
- C0566251
Description
Investigator Comment Log
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C0947611
Description
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
Description
Confirmation complete data in CRF
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0750484
- UMLS CUI [1,2]
- C3899518
Description
Investigator's signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator's name (print)
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
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Study conclusion, Investigator Comment Log, Investigator's signature
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C0022423 (UMLS CUI [1,2])
C2349954 (UMLS CUI [2,1])
C0566251 (UMLS CUI [2,2])
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C0947611 (UMLS CUI-2)
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C3899518 (UMLS CUI [1,2])
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