ID

33476

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 the investigational product and treatment confirmation form. It has to be filled in for study visit.

Link

https://clinicaltrials.gov/ct2/show/NCT00599612

Keywords

  1. 12/4/18 12/4/18 -
  2. 12/7/18 12/7/18 -
  3. 12/10/18 12/10/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

December 10, 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

Investigational product, treatment confirmation

Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Description

Subject identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Investigational product
Description

Investigational product

Alias
UMLS CUI-1
C0304229
Date of dose
Description

daay month year

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Time of dose
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Treatment confirmation
Description

Treatment confirmation

Alias
UMLS CUI-1
C0750484
UMLS CUI-2
C0087111
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing Interval?
Description

If no, record reason in following item.

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0178602
UMLS CUI [1,5]
C1272706
Reason for incorrect treatment
Description

Reason for incorrect treatment

Data type

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0549184
UMLS CUI [1,4]
C1298908

Similar models

Investigational product, treatment confirmation

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Investigational product
C0304229 (UMLS CUI-1)
Date of dose
Item
Date of dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time of dose
Item
Time of dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Treatment confirmation
C0750484 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing Interval?
text
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C1272706 (UMLS CUI [1,5])
Code List
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing Interval?
CL Item
Yes (Y)
CL Item
No (N)
Reason for incorrect treatment
Item
Reason for incorrect treatment
text
C0566251 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0549184 (UMLS CUI [1,3])
C1298908 (UMLS CUI [1,4])

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