ID

44403

Beschreibung

https://www.gsk-clinicalstudyregister.com/study/102886/003?search=study&study_ids=102886#csr Study ID : 102886/003 Clinical Study ID : 102886/003 Study Title :Safety, tolerance and preliminary pharmacokinetics of single ascending intravenous doses of halofantrine [SK&F 102886] in healthy male volunteers. Clinicaltrials.gov Identifier : Sponsor : GlaxoSmithKline Collaborators :N/A Phase :N/A Study Recruitment Status :Completed Generic Name :halofantrine Trade Name :Halfan Study Indication Malaria

Link

https://www.gsk-clinicalstudyregister.com/study/102886/003?search=study&study_ids=102886#csr

Stichworte

Versionen (2)
  1. 05.06.18 05.06.18 - Halim Ugurlu
  2. 20.09.21 20.09.21 -
Rechteinhaber

GlaxoSmithKline (GSK)

Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Safety, tolerance and preliminary pharmacokinetics of single ascending intravenous doses of halofantrine [SK&F 102886] in healthy male volunteers.

Englisch

Glucose assay, plasma drug assay, volunteer completion/withdrawal, investigator's statement, concominant medication, missing data form

1 Formulare  
Administration
Beschreibung

Administration

Alias
UMLS CUI-1
C1320722
Vol. No.
Beschreibung

Vol. No.

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Panel ID.
Beschreibung

Panel ID.

Datentyp

text

Alias
UMLS CUI [1]
C3846158
Study Period
Beschreibung

Study Period

Datentyp

text

Alias
UMLS CUI [1]
C2347804
Glucose Assay
Beschreibung

Glucose Assay

Alias
UMLS CUI-1
C0202042
Actual time of start of infusion
Beschreibung

start time infusion

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C0040223
Glucose Assay
Beschreibung

Glucose Assay

Alias
UMLS CUI-1
C0202042
Time Relative to start of infusion
Beschreibung

Time Relative to start of infusion

Datentyp

integer

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C0040223
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Actual time
Beschreibung

Actual time

Datentyp

time

Alias
UMLS CUI [1]
C0040223
Sample Taken
Beschreibung

Sample Taken

Datentyp

boolean

Alias
UMLS CUI [1]
C0200345
Initials
Beschreibung

Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Plasma Drug Assay
Beschreibung

Plasma Drug Assay

Alias
UMLS CUI-1
C1609077
UMLS CUI-2
C1261153
Actual time of start of infusion
Beschreibung

start of infusion

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0574032
UMLS CUI [1,3]
C0439659
Plasma Drug Assay
Beschreibung

Plasma Drug Assay

Alias
UMLS CUI-1
C1609077
UMLS CUI-2
C1261153
Time relative to start of infusion
Beschreibung

Time relative to start of infusion

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0304229
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Actual time
Beschreibung

Actual time

Datentyp

time

Alias
UMLS CUI [1]
C0040223
Sample Taken
Beschreibung

Sample Taken

Datentyp

boolean

Alias
UMLS CUI [1]
C0200345
Initials
Beschreibung

Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Volunteer Completion/Withdrawal
Beschreibung

Volunteer Completion/Withdrawal

Alias
UMLS CUI-1
C0805732
UMLS CUI-2
C2349954
Date/time
Beschreibung

Date/time

Datentyp

datetime

Alias
UMLS CUI [1]
C1264639
Did the volunteer complete the study?
Beschreibung

Did the volunteer complete the study?

Datentyp

boolean

Alias
UMLS CUI [1]
C2348577
If no, please complete the following
Beschreibung

Reason for withdrawal. Please tick the SINGLE most appropriate reason only

Datentyp

integer

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
Reason for withdrawal-Details
Beschreibung

Details

Datentyp

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
When did the volunteer last take any study medication?
Beschreibung

Please record to appropriate precision

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0946444
Investigator's checklist
Beschreibung

Investigator's checklist

Alias
UMLS CUI-1
C1707357
UMLS CUI-2
C0008961
Check all Adverse Event forms are up to date and complete
Beschreibung

all Adverse Event forms are up to date and complete

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0920316
UMLS CUI [1,3]
C0205197
Check that the Concominant Medication form is up to date
Beschreibung

Concominant Medication form is up to date

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0920316
UMLS CUI [1,3]
C0237400
Check that all pages are signed (thus indicating completion) and dated
Beschreibung

all pages are signed (thus indicating completion) and dated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1283174
UMLS CUI [1,2]
C1519316
Check that laboratory results are included
Beschreibung

laboratory results are included

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0920316
Recorder's initials
Beschreibung

Recorder's initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
date
Beschreibung

date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Study director
Beschreibung

Study director

Datentyp

text

Alias
UMLS CUI [1]
C0025081
date
Beschreibung

date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Investigator's Statement
Beschreibung

Investigator's Statement

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C1710187
I.........(the investigator) take full responsibility for the pages completed in this book.
Beschreibung

Investigator-take full responsibility

Datentyp

text

Alias
UMLS CUI [1,1]
C0678341
UMLS CUI [1,2]
C2826892
Study Director
Beschreibung

Study Director

Datentyp

text

Alias
UMLS CUI [1]
C0025081
date
Beschreibung

date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Concominant Medication
Beschreibung

Concominant Medication

Alias
UMLS CUI-1
C2347852
Drug name
Beschreibung

Drug name

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Dose
Beschreibung

units

Datentyp

text

Alias
UMLS CUI [1]
C3174092
Freq/day
Beschreibung

Freq/day

Datentyp

text

Alias
UMLS CUI [1]
C3476109
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Indication
Beschreibung

Fill in an Adverse Event form if necessary

Datentyp

text

Alias
UMLS CUI [1]
C3146298
Start Date and Time
Beschreibung

Start Date and Time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1301880
End Date and Time
Beschreibung

End Date and Time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1301880
Continuing at the end of the study
Beschreibung

Continuing at the end of the study

Datentyp

boolean

Alias
UMLS CUI [1]
C1553904
If no concominant medication is taken during the study, please select
Beschreibung

To be completed at the end of the study

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1298908
Missing Data-Human
Beschreibung

Missing Data-Human

Alias
UMLS CUI-1
C1705492
UMLS CUI-2
C1511726
Study Day
Beschreibung

Study Day

Datentyp

date

Alias
UMLS CUI [1]
C2826182
Missing Data Point
Beschreibung

Missing Data Point

Datentyp

text

Alias
UMLS CUI [1]
C0814891
Reason
Beschreibung

Reason

Datentyp

text

Alias
UMLS CUI [1]
C0392360
Initials
Beschreibung

Initials

Datentyp

text

Alias
UMLS CUI [1]
C3166278
Missing Data-Haem
Beschreibung

Missing Data-Haem

Alias
UMLS CUI-1
C1705492
UMLS CUI-2
C1511726
Study Day
Beschreibung

Study Day

Datentyp

date

Alias
UMLS CUI [1]
C2826182
Missing Data Point
Beschreibung

Missing Data Point

Datentyp

text

Alias
UMLS CUI [1]
C0814891
Reason
Beschreibung

Reason

Datentyp

text

Alias
UMLS CUI [1]
C0392360
Initials
Beschreibung

Initials

Datentyp

text

Alias
UMLS CUI [1]
C3166278
Missing Data-Clin
Beschreibung

Missing Data-Clin

Alias
UMLS CUI-1
C1705492
UMLS CUI-2
C1511726
Study Day
Beschreibung

Study Day

Datentyp

date

Alias
UMLS CUI [1]
C2826182
Missing Data Point
Beschreibung

Missing Data Point

Datentyp

text

Alias
UMLS CUI [1]
C0814891
Reason
Beschreibung

Reason

Datentyp

text

Alias
UMLS CUI [1]
C0392360
Initials
Beschreibung

Initials

Datentyp

text

Alias
UMLS CUI [1]
C3166278
Missing Data-Urine
Beschreibung

Missing Data-Urine

Alias
UMLS CUI-1
C1705492
UMLS CUI-2
C1511726
Study Day
Beschreibung

Study Day

Datentyp

date

Alias
UMLS CUI [1]
C2826182
Missing Data Point
Beschreibung

Missing Data Point

Datentyp

text

Alias
UMLS CUI [1]
C0814891
Reason
Beschreibung

Reason

Datentyp

text

Alias
UMLS CUI [1]
C0392360
Initials
Beschreibung

Initials

Datentyp

text

Alias
UMLS CUI [1]
C3166278
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Ähnliche Modelle

Glucose assay, plasma drug assay, volunteer completion/withdrawal, investigator's statement, concominant medication, missing data form

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administration
C1320722 (UMLS CUI-1)
Vol. No.
Item
Vol. No.
text
C2348585 (UMLS CUI [1])
Panel ID.
Item
Panel ID.
text
C3846158 (UMLS CUI [1])
Study Period
Item
Study Period
text
C2347804 (UMLS CUI [1])
Item Group
Glucose Assay
C0202042 (UMLS CUI-1)
start time infusion
Item
Actual time of start of infusion
datetime
C0574032 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Glucose Assay
C0202042 (UMLS CUI-1)
Item
Time Relative to start of infusion
integer
C0574032 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Time Relative to start of infusion
Code List
Time Relative to start of infusion
CL Item
-5 mins (1)
CL Item
+15 mins (2)
CL Item
+30 mins (3)
CL Item
+50 mins (4)
CL Item
+75 mins (5)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Sample Taken
Item
Sample Taken
boolean
C0200345 (UMLS CUI [1])
Initials
Item
Initials
text
C2986440 (UMLS CUI [1])
Item Group
Plasma Drug Assay
C1609077 (UMLS CUI-1)
C1261153 (UMLS CUI-2)
start of infusion
Item
Actual time of start of infusion
datetime
C0011008 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
Item Group
Plasma Drug Assay
C1609077 (UMLS CUI-1)
C1261153 (UMLS CUI-2)
Item
Time relative to start of infusion
integer
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Time relative to start of infusion
Code List
Time relative to start of infusion
CL Item
-0.5 hours (1)
CL Item
+0.25 hours (2)
CL Item
+0.5 hours (3)
CL Item
+0.83 hours (4)
CL Item
+2 hours (5)
CL Item
+3 hours (6)
CL Item
+5 hours (7)
CL Item
+7 hours (8)
CL Item
+10 hours (9)
CL Item
+12 hours (10)
CL Item
+24 hours (11)
CL Item
+48 hours (12)
CL Item
+72 hours (13)
CL Item
+144 hours (14)
CL Item
+216 hours (15)
CL Item
+336 hours (16)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Sample Taken
Item
Sample Taken
boolean
C0200345 (UMLS CUI [1])
Initials
Item
Initials
text
C2986440 (UMLS CUI [1])
Item Group
Volunteer Completion/Withdrawal
C0805732 (UMLS CUI-1)
C2349954 (UMLS CUI-2)
Date/time
Item
Date/time
datetime
C1264639 (UMLS CUI [1])
Did the volunteer complete the study?
Item
Did the volunteer complete the study?
boolean
C2348577 (UMLS CUI [1])
Item
If no, please complete the following
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for withdrawal
Code List
If no, please complete the following
CL Item
Significant adverse events (adverse events form must be completed) (3)
CL Item
Lack of subject compliance (4)
CL Item
Subject lost to follow-up (5)
CL Item
Protocol violation (specify below) (6)
CL Item
Concurrent disease (specify below) (7)
CL Item
Other reason (specify below) (8)
Reason for withdrawal
Item
Reason for withdrawal-Details
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
When did the volunteer last take any study medication
Item
When did the volunteer last take any study medication?
datetime
C0304229 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
Item Group
Investigator's checklist
C1707357 (UMLS CUI-1)
C0008961 (UMLS CUI-2)
all Adverse Event forms are up to date and complete
Item
Check all Adverse Event forms are up to date and complete
boolean
C0877248 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Concominant Medication form is up to date
Item
Check that the Concominant Medication form is up to date
boolean
C2347852 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C0237400 (UMLS CUI [1,3])
all pages are signed (thus indicating completion) and dated
Item
Check that all pages are signed (thus indicating completion) and dated
boolean
C1283174 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
laboratory results are included
Item
Check that laboratory results are included
boolean
C1254595 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
Recorder's initials
Item
Recorder's initials
text
C2986440 (UMLS CUI [1])
date
Item
date
date
C0011008 (UMLS CUI [1])
Study director
Item
Study director
text
C0025081 (UMLS CUI [1])
date
Item
date
date
C0011008 (UMLS CUI [1])
Item Group
Investigator's Statement
C0008961 (UMLS CUI-1)
C1710187 (UMLS CUI-2)
Investigator-take full responsibility
Item
I.........(the investigator) take full responsibility for the pages completed in this book.
text
C0678341 (UMLS CUI [1,1])
C2826892 (UMLS CUI [1,2])
Study Director
Item
Study Director
text
C0025081 (UMLS CUI [1])
date
Item
date
date
C0011008 (UMLS CUI [1])
Item Group
Concominant Medication
C2347852 (UMLS CUI-1)
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1])
Freq/day
Item
Freq/day
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Indication
Item
Indication
text
C3146298 (UMLS CUI [1])
Start Date and Time
Item
Start Date and Time
datetime
C0808070 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
End Date and Time
Item
End Date and Time
datetime
C0806020 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Continuing at the end of the study
Item
Continuing at the end of the study
boolean
C1553904 (UMLS CUI [1])
undefined item
Item
If no concominant medication is taken during the study, please select
boolean
C2347852 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
Item Group
Missing Data-Human
C1705492 (UMLS CUI-1)
C1511726 (UMLS CUI-2)
Study Day
Item
Study Day
date
C2826182 (UMLS CUI [1])
Missing Data Point
Item
Missing Data Point
text
C0814891 (UMLS CUI [1])
Reason
Item
Reason
text
C0392360 (UMLS CUI [1])
Initials
Item
Initials
text
C3166278 (UMLS CUI [1])
Item Group
Missing Data-Haem
C1705492 (UMLS CUI-1)
C1511726 (UMLS CUI-2)
Study Day
Item
Study Day
date
C2826182 (UMLS CUI [1])
Missing Data Point
Item
Missing Data Point
text
C0814891 (UMLS CUI [1])
Reason
Item
Reason
text
C0392360 (UMLS CUI [1])
Initials
Item
Initials
text
C3166278 (UMLS CUI [1])
Item Group
Missing Data-Clin
C1705492 (UMLS CUI-1)
C1511726 (UMLS CUI-2)
Study Day
Item
Study Day
date
C2826182 (UMLS CUI [1])
Missing Data Point
Item
Missing Data Point
text
C0814891 (UMLS CUI [1])
Reason
Item
Reason
text
C0392360 (UMLS CUI [1])
Initials
Item
Initials
text
C3166278 (UMLS CUI [1])
Item Group
Missing Data-Urine
C1705492 (UMLS CUI-1)
C1511726 (UMLS CUI-2)
Study Day
Item
Study Day
date
C2826182 (UMLS CUI [1])
Missing Data Point
Item
Missing Data Point
text
C0814891 (UMLS CUI [1])
Reason
Item
Reason
text
C0392360 (UMLS CUI [1])
Initials
Item
Initials
text
C3166278 (UMLS CUI [1])
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