ID

41067

Beskrivning

Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

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Versioner (1)
  1. 18-06-20 18-06-20 -
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GlaxoSmithKline

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18 juni 2020

DOI

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Creative Commons BY-NC 4.0
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Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447

Engelsk

Pharmacokinetics - Blood

1 Formulär  
Administrative
Beskrivning

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Pharmacokinetics - Blood (Session 1)
Beskrivning

Pharmacokinetics - Blood (Session 1)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beskrivning

Time Relative to Dosing

Datatyp

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Beskrivning

Date Sample Taken

Datatyp

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Beskrivning

Actual Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Sample Number
Beskrivning

Sample Number

Datatyp

integer

Alias
UMLS CUI [1]
C1299222
Pharmacokinetics - Blood (Session 1)
Beskrivning

Pharmacokinetics - Blood (Session 1)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beskrivning

Time Relative to Dosing

Datatyp

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Beskrivning

Date Sample Taken

Datatyp

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Beskrivning

Actual Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Sample Number
Beskrivning

Sample Number

Datatyp

integer

Alias
UMLS CUI [1]
C1299222
Pharmacokinetics - Blood (Session 2)
Beskrivning

Pharmacokinetics - Blood (Session 2)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beskrivning

Time Relative to Dosing

Datatyp

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Beskrivning

Date Sample Taken

Datatyp

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Beskrivning

Actual Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Sample Number
Beskrivning

Sample Number

Datatyp

integer

Alias
UMLS CUI [1]
C1299222
Pharmacokinetics - Blood (Session 2)
Beskrivning

Pharmacokinetics - Blood (Session 2)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beskrivning

Time Relative to Dosing

Datatyp

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Beskrivning

Date Sample Taken

Datatyp

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Beskrivning

Actual Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Sample Number
Beskrivning

Sample Number

Datatyp

integer

Alias
UMLS CUI [1]
C1299222
Pharmacokinetics - Blood (Session 3)
Beskrivning

Pharmacokinetics - Blood (Session 3)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beskrivning

Time Relative to Dosing

Datatyp

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Beskrivning

Date Sample Taken

Datatyp

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Beskrivning

Actual Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Sample Number
Beskrivning

Sample Number

Datatyp

integer

Alias
UMLS CUI [1]
C1299222
Pharmacokinetics - Blood (Session 3)
Beskrivning

Pharmacokinetics - Blood (Session 3)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beskrivning

Time Relative to Dosing

Datatyp

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Beskrivning

Date Sample Taken

Datatyp

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Beskrivning

Actual Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Sample Number
Beskrivning

Sample Number

Datatyp

integer

Alias
UMLS CUI [1]
C1299222
Pharmacokinetics - Blood (Session 4)
Beskrivning

Pharmacokinetics - Blood (Session 4)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beskrivning

Time Relative to Dosing

Datatyp

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Beskrivning

Date Sample Taken

Datatyp

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Beskrivning

Actual Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Sample Number
Beskrivning

Sample Number

Datatyp

integer

Alias
UMLS CUI [1]
C1299222
Pharmacokinetics - Blood (Session 4)
Beskrivning

Pharmacokinetics - Blood (Session 4)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beskrivning

Time Relative to Dosing

Datatyp

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Beskrivning

Date Sample Taken

Datatyp

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Beskrivning

Actual Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Sample Number
Beskrivning

Sample Number

Datatyp

integer

Alias
UMLS CUI [1]
C1299222
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Similar models

Pharmacokinetics - Blood

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Pharmacokinetics - Blood (Session 1)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Predose (1)
CL Item
0.5 hr (2)
CL Item
1 hr (3)
CL Item
1.5 hr (4)
CL Item
2 hr (5)
CL Item
3 hr (6)
CL Item
4 hr (7)
CL Item
6 hr (8)
CL Item
8 hr (9)
CL Item
12 hr (10)
CL Item
24 hr (11)
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Item
Sample Number
integer
C1299222 (UMLS CUI [1])
Sample Number
Code List
Sample Number
CL Item
101 (1)
CL Item
102 (2)
CL Item
103 (3)
CL Item
104 (4)
CL Item
105 (5)
CL Item
106 (6)
CL Item
107 (7)
CL Item
108 (8)
CL Item
109 (9)
CL Item
110 (10)
CL Item
111 (11)
Item Group
Pharmacokinetics - Blood (Session 1)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Predose  (1)
CL Item
0.5 hr  (2)
CL Item
1 hr  (3)
CL Item
1.5 hr  (4)
CL Item
2 hr  (5)
CL Item
3 hr  (6)
CL Item
4 hr  (7)
CL Item
6 hr  (8)
CL Item
8 hr  (9)
CL Item
12 hr  (10)
CL Item
24 hr (11)
CL Item
36h (12)
CL Item
48hr (13)
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Item
Sample Number
integer
C1299222 (UMLS CUI [1])
Sample Number
Code List
Sample Number
CL Item
112 (1)
CL Item
113 (2)
CL Item
114 (3)
CL Item
115 (4)
CL Item
116 (5)
CL Item
117 (6)
CL Item
118 (7)
CL Item
119 (8)
CL Item
120 (9)
CL Item
121 (10)
CL Item
122 (11)
CL Item
123 (12)
CL Item
124 (13)
Item Group
Pharmacokinetics - Blood (Session 2)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Predose  (1)
CL Item
0.5 hr  (2)
CL Item
1 hr  (3)
CL Item
1.5 hr  (4)
CL Item
2 hr  (5)
CL Item
3 hr  (6)
CL Item
4 hr  (7)
CL Item
6 hr  (8)
CL Item
8 hr  (9)
CL Item
12 hr (10)
CL Item
24 hr (11)
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Item
Sample Number
integer
C1299222 (UMLS CUI [1])
Sample Number
Code List
Sample Number
CL Item
201 (1)
CL Item
202 (2)
CL Item
203 (3)
CL Item
204 (4)
CL Item
205 (5)
CL Item
206 (6)
CL Item
207 (7)
CL Item
208 (8)
CL Item
209 (9)
CL Item
210 (10)
CL Item
211 (11)
Item Group
Pharmacokinetics - Blood (Session 2)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Predose  (1)
CL Item
0.5 hr  (2)
CL Item
1 hr  (3)
CL Item
1.5 hr  (4)
CL Item
2 hr  (5)
CL Item
3 hr  (6)
CL Item
4 hr  (7)
CL Item
6 hr  (8)
CL Item
8 hr  (9)
CL Item
12 hr (10)
CL Item
24 hr (11)
CL Item
36 hr (12)
CL Item
48 hr (13)
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Item
Sample Number
integer
C1299222 (UMLS CUI [1])
Sample Number
Code List
Sample Number
CL Item
212 (1)
CL Item
213 (2)
CL Item
214 (3)
CL Item
215 (4)
CL Item
216 (5)
CL Item
217 (6)
CL Item
218 (7)
CL Item
219 (8)
CL Item
220 (9)
CL Item
221 (10)
CL Item
222 (11)
CL Item
223 (12)
CL Item
224 (13)
Item Group
Pharmacokinetics - Blood (Session 3)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Predose  (1)
CL Item
0.5 hr  (2)
CL Item
1 hr  (3)
CL Item
1.5 hr  (4)
CL Item
2 hr  (5)
CL Item
3 hr  (6)
CL Item
4 hr  (7)
CL Item
6 hr  (8)
CL Item
8 hr  (9)
CL Item
12 hr (10)
CL Item
24 hr (11)
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Item
Sample Number
integer
C1299222 (UMLS CUI [1])
Sample Number
Code List
Sample Number
CL Item
301 (1)
CL Item
302 (2)
CL Item
303 (3)
CL Item
304 (4)
CL Item
305 (5)
CL Item
306 (6)
CL Item
307 (7)
CL Item
308 (8)
CL Item
309 (9)
CL Item
310 (10)
CL Item
311 (11)
Item Group
Pharmacokinetics - Blood (Session 3)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Predose  (1)
CL Item
0.5 hr  (2)
CL Item
1 hr  (3)
CL Item
1.5 hr  (4)
CL Item
2 hr  (5)
CL Item
3 hr  (6)
CL Item
4 hr  (7)
CL Item
6 hr  (8)
CL Item
8 hr  (9)
CL Item
12 hr (10)
CL Item
24 hr (11)
CL Item
36 hr (12)
CL Item
48 hr (13)
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Item
Sample Number
integer
C1299222 (UMLS CUI [1])
Sample Number
Code List
Sample Number
CL Item
312 (1)
CL Item
313 (2)
CL Item
314 (3)
CL Item
315 (4)
CL Item
316 (5)
CL Item
317 (6)
CL Item
318 (7)
CL Item
319 (8)
CL Item
320 (9)
CL Item
321 (10)
CL Item
322 (11)
CL Item
323 (12)
CL Item
324 (13)
Item Group
Pharmacokinetics - Blood (Session 4)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Predose  (1)
CL Item
0.5 hr  (2)
CL Item
1 hr  (3)
CL Item
1.5 hr  (4)
CL Item
2 hr  (5)
CL Item
3 hr  (6)
CL Item
4 hr  (7)
CL Item
6 hr  (8)
CL Item
8 hr  (9)
CL Item
12 hr (10)
CL Item
24 hr (11)
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Item
Sample Number
integer
C1299222 (UMLS CUI [1])
Sample Number
Code List
Sample Number
CL Item
401 (1)
CL Item
402 (2)
CL Item
403 (3)
CL Item
404 (4)
CL Item
405 (5)
CL Item
406 (6)
CL Item
407 (7)
CL Item
408 (8)
CL Item
409 (9)
CL Item
410 (10)
CL Item
411 (11)
Item Group
Pharmacokinetics - Blood (Session 4)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Predose  (1)
CL Item
0.5 hr  (2)
CL Item
1 hr  (3)
CL Item
1.5 hr  (4)
CL Item
2 hr  (5)
CL Item
3 hr  (6)
CL Item
4 hr  (7)
CL Item
6 hr  (8)
CL Item
8 hr  (9)
CL Item
12 hr (10)
CL Item
24 hr (11)
CL Item
36 hr (12)
CL Item
48 hr (13)
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Item
Sample Number
integer
C1299222 (UMLS CUI [1])
Sample Number
Code List
Sample Number
CL Item
412 (1)
CL Item
413 (2)
CL Item
414 (3)
CL Item
415 (4)
CL Item
416 (5)
CL Item
417 (6)
CL Item
418 (7)
CL Item
419 (8)
CL Item
420 (9)
CL Item
421 (10)
CL Item
422 (11)
CL Item
423 (12)
CL Item
424 (13)
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