ID

44403

Description

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

Keywords

Versions (2)
  1. 6/5/18 6/5/18 - Halim Ugurlu
  2. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

September 20, 2021

DOI

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License

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.

English

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

1 forms  
Administration
Description

Administration

Alias
UMLS CUI-1
C1320722
Vol. No.
Description

Vol. No.

Data type

text

Alias
UMLS CUI [1]
C2348585
Panel ID.
Description

Panel ID.

Data type

text

Alias
UMLS CUI [1]
C3846158
Study Period
Description

Study Period

Data type

text

Alias
UMLS CUI [1]
C2347804
Glucose Assay
Description

Glucose Assay

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

start time infusion

Data type

datetime

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

Glucose Assay

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

Time Relative to start of infusion

Data type

integer

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

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Actual time
Description

Actual time

Data type

time

Alias
UMLS CUI [1]
C0040223
Sample Taken
Description

Sample Taken

Data type

boolean

Alias
UMLS CUI [1]
C0200345
Initials
Description

Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Plasma Drug Assay
Description

Plasma Drug Assay

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

start of infusion

Data type

datetime

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

Plasma Drug Assay

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

Time relative to start of infusion

Data type

integer

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

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Actual time
Description

Actual time

Data type

time

Alias
UMLS CUI [1]
C0040223
Sample Taken
Description

Sample Taken

Data type

boolean

Alias
UMLS CUI [1]
C0200345
Initials
Description

Initials

Data type

text

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

Volunteer Completion/Withdrawal

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

Date/time

Data type

datetime

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

Did the volunteer complete the study?

Data type

boolean

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

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

Data type

integer

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

Details

Data type

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?
Description

Please record to appropriate precision

Data type

datetime

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

Investigator's checklist

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

all Adverse Event forms are up to date and complete

Data type

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
Description

Concominant Medication form is up to date

Data type

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
Description

all pages are signed (thus indicating completion) and dated

Data type

boolean

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

laboratory results are included

Data type

boolean

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

Recorder's initials

Data type

text

Alias
UMLS CUI [1]
C2986440
date
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Study director
Description

Study director

Data type

text

Alias
UMLS CUI [1]
C0025081
date
Description

date

Data type

date

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

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.
Description

Investigator-take full responsibility

Data type

text

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

Study Director

Data type

text

Alias
UMLS CUI [1]
C0025081
date
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Concominant Medication
Description

Concominant Medication

Alias
UMLS CUI-1
C2347852
Drug name
Description

Drug name

Data type

text

Alias
UMLS CUI [1]
C2360065
Dose
Description

units

Data type

text

Alias
UMLS CUI [1]
C3174092
Freq/day
Description

Freq/day

Data type

text

Alias
UMLS CUI [1]
C3476109
Route
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Indication
Description

Fill in an Adverse Event form if necessary

Data type

text

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

Start Date and Time

Data type

datetime

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

End Date and Time

Data type

datetime

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

Continuing at the end of the study

Data type

boolean

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

To be completed at the end of the study

Data type

boolean

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

Missing Data-Human

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

Study Day

Data type

date

Alias
UMLS CUI [1]
C2826182
Missing Data Point
Description

Missing Data Point

Data type

text

Alias
UMLS CUI [1]
C0814891
Reason
Description

Reason

Data type

text

Alias
UMLS CUI [1]
C0392360
Initials
Description

Initials

Data type

text

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

Missing Data-Haem

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

Study Day

Data type

date

Alias
UMLS CUI [1]
C2826182
Missing Data Point
Description

Missing Data Point

Data type

text

Alias
UMLS CUI [1]
C0814891
Reason
Description

Reason

Data type

text

Alias
UMLS CUI [1]
C0392360
Initials
Description

Initials

Data type

text

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

Missing Data-Clin

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

Study Day

Data type

date

Alias
UMLS CUI [1]
C2826182
Missing Data Point
Description

Missing Data Point

Data type

text

Alias
UMLS CUI [1]
C0814891
Reason
Description

Reason

Data type

text

Alias
UMLS CUI [1]
C0392360
Initials
Description

Initials

Data type

text

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

Missing Data-Urine

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

Study Day

Data type

date

Alias
UMLS CUI [1]
C2826182
Missing Data Point
Description

Missing Data Point

Data type

text

Alias
UMLS CUI [1]
C0814891
Reason
Description

Reason

Data type

text

Alias
UMLS CUI [1]
C0392360
Initials
Description

Initials

Data type

text

Alias
UMLS CUI [1]
C3166278
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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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