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ID
44401
Beschrijving
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
Trefwoorden
Versies (2)
- 05-06-18 05-06-18 - Halim Ugurlu
- 20-09-21 20-09-21 -
Houder van rechten
GlaxoSmithKline (GSK)
Geüploaded op
20 september 2021
DOI
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Licentie
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.
Administration, demographics, inclusion criteria, exclusion criteria, infusion details, ecg, alcohol/drug screening, baseline/advers events
Similar models
Administration, demographics, inclusion criteria, exclusion criteria, infusion details, ecg, alcohol/drug screening, baseline/advers events
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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])
Date and Time
Item
Date and Time
datetime
C1264639 (UMLS CUI [1])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
CL Item
Caucasian/European (1)
CL Item
Asian (2)
CL Item
Black (3)
CL Item
Oriental (4)
CL Item
Other, please specify (5)
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Age
Item
Is the volunteer aged between 21 and 39 years?
boolean
C0001779 (UMLS CUI [1])
compherensive pre-study medical examination
Item
Has the volunteer passed a compherensive pre-study medical examination during the week prior to the start of each study section, including: -medical history -clinical examination -electrocardiography (12 leads) -blood pressure -weight and height determination -pulmonary function test -haematological, clinical chemistry examinations, urinalysis and drug screening?
boolean
C0262926 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0031809 (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])
pathological findings
Item
Does the volunteer have pathological findings in any of the investigations stated in the Inclusion Criteria?
boolean
C0205469 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
receiving medicine
Item
Is the volunteer currently receiving, or taken within the previous 7 days prior to dosing, any other medicine (prescribed or over-the-counter drugs) ?
boolean
C2826257 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
received a research drug
Item
Has the volunteer received a research drug within the last 8 weeks (i.e, a compound which has not been granted a product licence) ?
boolean
C0013230 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,2])
alcohol abuse and/or have taken drugs of abuse
Item
Is the volunteer known to practice alcohol abuse and/or have taken drugs of abuse (e.g. as shown by a positive finding in the drug screen) ?
boolean
C0085762 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C0038586 (UMLS CUI [2])
weight/height ratio deviations
Item
Has the volunteer weight/height ratio deviations of more than 25% from the average (the average may be calculated by expressing the height above 100 m as a figure expressed in kg (Broca Formula) )
boolean
C0005890 (UMLS CUI [1,1])
C0005910 (UMLS CUI [1,2])
C0005910 (UMLS CUI [1,2])
allergic status
Item
Does the volunteer have a known or suspected allergic status?
boolean
C0018759 (UMLS CUI [1,1])
C0155877 (UMLS CUI [1,2])
C1527304 (UMLS CUI [1,3])
C0155877 (UMLS CUI [1,2])
C1527304 (UMLS CUI [1,3])
history of psychiatric disorders, epilepsy or seizures
Item
Does the volunteer have a history of psychiatric disorders, epilepsy or seizures?
boolean
C0262926 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0036572 (UMLS CUI [1,3])
C0014544 (UMLS CUI [1,4])
C0004936 (UMLS CUI [1,2])
C0036572 (UMLS CUI [1,3])
C0014544 (UMLS CUI [1,4])
anti-malarial frugs within the last 12 months
Item
Has the volunteer taken anti-malarial frugs within the last 12 months?
boolean
C0003374 (UMLS CUI [1])
Date of infusion
Item
Date of infusion
date
C0574032 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Time commenced
Item
Time commenced
time
C0011008 (UMLS CUI [1,1])
C0451613 (UMLS CUI [1,2])
C0451613 (UMLS CUI [1,2])
Time completed
Item
Time completed
time
C0574032 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Duration of infusion
Item
Duration of infusion
integer
C0444921 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0574032 (UMLS CUI [1,2])
Volunteer weight on Day-1
Item
Volunteer weight on Day-1
float
C0005910 (UMLS CUI [1])
Volume of infusion
Item
Volume of infusion
integer
C0574032 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
C0449468 (UMLS CUI [1,2])
Dose checked and administred by
Item
Dose checked and administred by
text
C0178602 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0574032 (UMLS CUI [1,2])
Item
Time Relative to start of infusion
integer
C0574032 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
CL Item
-0.5 to 0 hours (1)
CL Item
0 to +0.5 hours (2)
CL Item
+0.5 to +1.5 hours (3)
CL Item
+1.5 to 2.5 hours (4)
CL Item
+2.5 to +3.5 hours (5)
CL Item
+3.5 to +4.5 hours (6)
CL Item
+4.5 to +5.5 hours (7)
CL Item
+5.5 to +6.5 hours (8)
CL Item
+6.5 to +7.5 hours (9)
CL Item
+7.5 to +8.5 hours (10)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Couplets (per time inverval)
Item
Couplets (per time inverval)
text
C0429001 (UMLS CUI [1])
Bigeminus
Item
Bigeminus (per time interval)
text
C0262662 (UMLS CUI [1])
EVPB (per time interval)
Item
EVPB (per time interval)
text
C0151636 (UMLS CUI [1])
VPB
Item
VPB (per time interval)
text
C0865677 (UMLS CUI [1])
initials
Item
initials
text
C2986440 (UMLS CUI [1])
ECG recordings carried out
Item
Were there any ECG recordings carried out?
boolean
C1623258 (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])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
CL Item
-15 mins (1)
CL Item
+35 mins (2)
CL Item
+0.5 to +1.5 hours (3)
CL Item
+1 hour (4)
CL Item
+2.5 hours (5)
CL Item
+4.5 hours (6)
CL Item
+7.5 hours (7)
CL Item
+10.5 hours (8)
CL Item
+25.5 hours (9)
CL Item
+49.25 hours (10)
Date and time taken
Item
Date and time taken
datetime
C0011008 (UMLS CUI [1])
ECG normal
Item
Is the ECG normal
boolean
C0522054 (UMLS CUI [1])
Any changes
Item
Any changes
boolean
C0855329 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Initials
Item
Initials
text
C2986440 (UMLS CUI [1])
date
Item
date
date
C0011008 (UMLS CUI [1])
CL Item
Day -1 (1)
CL Item
Day 1 (2)
CL Item
Day +1 (3)
CL Item
Day +2 (4)
CL Item
Day +3 (5)
CL Item
Day +6 (6)
CL Item
Day +9 (7)
CL Item
Day +14 (8)
Date and time sample taken
Item
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
any alcohol detected
Item
Was there any alcohol detected?
boolean
C0202306 (UMLS CUI [1])
initials
Item
initials
text
C2986440 (UMLS CUI [1])
CL Item
Day -1 (1)
CL Item
Day 1 (2)
Date and time sample taken
Item
Date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Drugs detected
Item
Were there any Drugs detected?
boolean
C1511790 (UMLS CUI [1,1])
C1254351 (UMLS CUI [1,2])
C1254351 (UMLS CUI [1,2])
Type of drug/compound found
Item
Type of drug/compound found
text
C0457591 (UMLS CUI [1])
Contra indicated?
Item
Contra indicated?
boolean
C1301624 (UMLS CUI [1])
Initials Lab
Item
Initials Lab
text
C0022877 (UMLS CUI [1])
Initials Physician
Item
Initials Physician
text
C2986440 (UMLS CUI [1,1])
C2826892 (UMLS CUI [1,2])
C2826892 (UMLS CUI [1,2])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Felt different in any way over tha last few days
Item
Have you felt different in any way over the last few days?
boolean
C0559546 (UMLS CUI [1])
ADECS Code
Item
ADECS Code
text
C0805701 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Event Observed (describe)
Item
Event Observed (describe)
text
C0877248 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
Onset date and time
Item
Onset date and time
datetime
C2826806 (UMLS CUI [1])
End date and time
Item
End date and time
datetime
C2826793 (UMLS CUI [1])
Event duration
Item
Event duration
text
C0449238 (UMLS CUI [1])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Once (1)
CL Item
Consant (2)
CL Item
Intermittent (3)
CL Item
Event continuing (1)
CL Item
Event resolved (2)
Recorder's signature
Item
Recorder's signature
text
C1519316 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0035173 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Study Director's Signature
Item
Study Director's Signature
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
adverse event observed or elicited
Item
Do you feel different in any way since starting the new treatment or since the last visit?
boolean
C0559546 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
ADECS Code
Item
ADECS Code
text
C0805701 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Event observed (describe)
Item
Event observed (describe)
text
C0877248 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
Onset date and time
Item
Onset date and time
datetime
C2985916 (UMLS CUI [1])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Event continuing (1)
CL Item
event resolved (2)
CL Item
Once (1)
CL Item
Constant (2)
CL Item
Intermittent (3)
End date and time
Item
End date and time
datetime
C2826793 (UMLS CUI [1])
Event (or severity) duration
Item
Event (or severity) duration
text
C0877248 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
Item
Relation to investigational drug
integer
C0877248 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
CL Item
Unrelated (1)
CL Item
Possibly related (2)
CL Item
Related (3)
Item
Present before or at baseline assessment?
integer
C0011900 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
C1444637 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
CL Item
None (1)
CL Item
Dose interrupted (2)
CL Item
Dose changed (3)
CL Item
Drug withdrawn* (4)
Item
Outcome of event (select more than one if necessary)
integer
C1705586 (UMLS CUI [1])
CL Item
Corrective therapy given** (1)
CL Item
Life threatening* (2)
CL Item
Significantly disabling* (3)
CL Item
Pat. hosp./Hosp. prolonged* (4)
CL Item
Patient died* (5)
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])