ID

33483

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, Pregnancy Information, 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)
  1. 12/7/18 12/7/18 -
  2. 12/11/18 12/11/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

December 11, 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

English

Study conclusion, Pregnancy Information, Investigator Comment Log, Investigator's signature

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Study conclusion
Description

Study conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of subject completion or withdrawal
Description

day month year Refer to protocol section(s) to evaluate subject completion or withdrawal from the study. If subject completed the study 'Date of subject completion (or withdrawal)' must match the last scheduled study visit date. If the subject withdrew from the study 'Date of subject completion or withdrawal' is the date at which the investigator agreed, or determined, that the subject's participation in the study was over. Typically, this will be the date of the subject's last visit to the investigator but an alternative date of withdrawal may be used in the circumstances described below. In the event that the contact between subject and investigator is conducted remotely during the planned study period (as defined in the protocol, i.e., by phone, by mail or electronic e-mail) and the subject is deemed to have withdrawn or been withdrawn, the date of withdrawal is considered to be the date on which the investigatoris made aware of the withdrawal or makes the decision to withdraw the subject. In the event that the subject is lost to follow-up, the date of withdrawal is considered to be the last point at which the investigator had contact with the subject during the study period (as defined in the protocol). Note: An 'actual contact' is defined as an interaction between the subject and the investigator or investigator's designee, where the investigatorldesignee has the opportunity to query the subject about the subject's status. This would include clinic visits, telephone contacts or electronic e-mail.

Data type

date

Alias
UMLS CUI [1]
C1549507
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C0422727
Was the subject withdrawn from the study?
Description

Subject's withdraw

Data type

text

Alias
UMLS CUI [1]
C2349954
If subject was withdrawn from study, tick one primary reason for withdrawal
Description

You must only tick ONE Primary reason for withdrawal If the subject is withdrawn from the study, only tick 'Investigator discretion' or 'Withdrew consent' if the reason for withdrawaldoes not fit into any of the other primary reason categories. Adverse event: Use this primary reason only if the subject discontinues medication and is withdrawn from the study due to an adverse event. If the subject was withdrawn due to an adverse event, confirm that details recorded correspond with details on the appropriate (Non-)Serious Adverse Event page. Protocol deviation Study closed/terminated: Use this primary reason only if the site is closed or the study is terminated by the sponsor. Lost to follow-up: In the event that the subject is lost to follow-up, the date of withdrawal is considered to be the last point at which the investigator had contact with the subject. Investigator discretion: Use this primary reason only if the subject discontinues from tile study at the investigator's discretion and none of the other reasons apply. Withdrew consent: Use this primary reason only if the subject discontinues from the study because consent has been withdrawn and none of the other reasons apply (e.g., subject found the travel time to the clinic too long and does not want to continue in the study). Only use 'specify' to provide detailed information which is not covered by predefined sub-reasons provided. Note: An 'actual contact' is defined as an interaction between the subject and the investigator or investigator's designee, where the investigatorldesignee has the opportunity to query the subject about the subject's status. This would include clinic visits, telephone contacts or electronic e-mail.

Data type

integer

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0566251
If you tick "Investigator discretion", please specify
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
Pregnancy Information
Description

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did a female partner of the male subject become pregnant during the study?
Description

If Yes, complete Pregnancy Notification form.

Data type

text

Alias
UMLS CUI [1]
C0919624
Investigator Comment Log
Description

Investigator Comment Log

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C0947611
CRF page number if applicable
Description

CRF page number

Data type

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1516308
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Investigator's signature
Description

Investigator's signature

Alias
UMLS CUI-1
C2346576
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Description

Confirmation complete data in CRF

Data type

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C3899518
Investigator's signature
Description

Investigator's signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigator's name (print)
Description

Investigator's name (print)

Data type

text

Alias
UMLS CUI [1]
C2826892
Date of signature
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Study conclusion, Pregnancy Information, Investigator Comment Log, Investigator's signature

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Study conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C1549507 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C0422727 (UMLS CUI [2,2])
Item
Was the subject withdrawn from the study?
text
C2349954 (UMLS CUI [1])
Subject's withdraw
Code List
Was the subject withdrawn from the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
If subject was withdrawn from study, tick one primary reason for withdrawal
integer
C2349954 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Withdraw, reason
Code List
If subject was withdrawn from study, tick one primary reason for withdrawal
CL Item
Adverse event  (1)
CL Item
Protocol deviation (2)
CL Item
Subject reached protocol defined stopping criteria (3)
CL Item
Study closed/terminated (4)
CL Item
Lost to follow-up (5)
CL Item
Investigator discretion  (6)
CL Item
Withdrew consent (7)
Investigator discretion, specification
Item
If you tick "Investigator discretion", please specify
text
C0008961 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C2349954 (UMLS CUI [2,1])
C0566251 (UMLS CUI [2,2])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did a female partner of the male subject become pregnant during the study?
text
C0919624 (UMLS CUI [1])
Pregnancy of female partner of subject during study
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Applicable (subject is female, female partner not of childbearing potential or no female partner) (X)
Item Group
Investigator Comment Log
C0008961 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
CRF page number
Item
CRF page number if applicable
integer
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Investigator's signature
C2346576 (UMLS CUI-1)
Confirmation complete data in CRF
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
boolean
C0750484 (UMLS CUI [1,1])
C3899518 (UMLS CUI [1,2])
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator's name (print)
Item
Investigator's name (print)
text
C2826892 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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