ID

40846

Beschreibung

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. This form is used to track sample collections during Treatment Period 1 & Treatment Period 2 starting prior with a sample collection prior to the drug administration. Urine and faeces collection can be ended at 168 if more than 90% of the radioactive dose administered was recovered from all matrices by then.

Stichworte

Versionen (1)
  1. 24.05.20 24.05.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

24. Mai 2020

DOI

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Lizenz

Creative Commons BY-NC 4.0
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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933

Englisch

Pharmacokinetics – blood; Metabolite profiling – plasma, Urine, Faeces

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Visit Type
Beschreibung

Visit Type

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Pharmacokinetics - Blood
Beschreibung

Pharmacokinetics - Blood

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

0.25 hr (immediately post-infusion) sample to be taken only in Treatment Period 1.

Datentyp

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Scheduled Time
Beschreibung

Blood sample Scheduled Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C1301732
Date Sample Taken
Beschreibung

Blood sample Date Sample Taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Actual Time
Beschreibung

Blood sample Actual Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
7 mL Sample Check Yes if taken
Beschreibung

Blood sample Taken

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1883727
Sample Number
Beschreibung

The samples numbered 1xx are to be taken at Treatment Period 1. The samples numbered 2xx are to be taken at Treatment Period 2. The samples are to be taken consectively at following moments: 101, 201: Predose 102: 0.25 hr (immediately post-infusion) 103, 202: 0.5 hr post-infusion 104, 203: 1 hr 105, 204: 2 hr 106, 205: 3 hr 107, 206: 4 hr 108, 207: 6 hr 109, 208: 10 hr 110, 209: 16 hr 111, 210: 24 hr 112, 211: 36 hr 113, 212: 48 hr 114, 213: 72 hr

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1299222
Metabolite Profiling - Plasma
Beschreibung

Metabolite Profiling - Plasma

Alias
UMLS CUI-1
C0005507
UMLS CUI-2
C0870883
UMLS CUI-3
C0032105
Planned Relative Time
Beschreibung

A predose blood sample (approximately 20 mL) will be taken from one subject (selected at random.) 0.25 hr (immediately post-infusion) sample to be taken only in Treatment Period 1. 16 hr sample to be taken only in Treatment Period 2.

Datentyp

text

Alias
UMLS CUI [1,1]
C0032105
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0439564
UMLS CUI [1,4]
C1301732
Scheduled Time
Beschreibung

Plasma sample collection Scheduled Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0032105
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C1301732
Date Sample Taken
Beschreibung

Plasma sample collection Date Sample Taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0032105
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
Actual Time
Beschreibung

Plasma sample collection Actual Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0032105
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0040223
30 mL Sample Check Yes if taken
Beschreibung

Plasma sample collection Taken

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032105
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1883727
Sample Number
Beschreibung

The samples numbered 1xx are to be taken at Treatment Period 1. The samples numbered 2xx are to be taken at Treatment Period 2. The samples are to be taken consectively at following moments: 115, 214: Predose 116: 0.25 hr post-infusion 117, 215: 1 hr 118, 216: 3 hr 119, 217: 6 hr 218: 16 hr

Datentyp

integer

Alias
UMLS CUI [1,1]
C0032105
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1299222
Metabolite Profiling - Urine
Beschreibung

Metabolite Profiling - Urine

Alias
UMLS CUI-1
C0005507
UMLS CUI-2
C0870883
UMLS CUI-3
C0042036
Planned Relative Time Interval
Beschreibung

Urine sample collection Planned Relative Time Interval

Datentyp

text

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1272706
UMLS CUI [1,4]
C1301732
Start Date
Beschreibung

Urine sample collection Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0808070
Actual Start Time
Beschreibung

Urine sample collection Actual Start Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C1301880
Stop Date
Beschreibung

Urine sample collection Stop Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0806020
Actual Stop Time
Beschreibung

Urine sample collection Actual Stop Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C1522314
Was all of the sample collected for this interval?
Beschreibung

Urine sample collection: Was all of the sample collected for this interval?

Datentyp

text

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0205197
Sample Number
Beschreibung

The samples numbered 1xx are to be taken at Treatment Period 1. The samples numbered 2xx are to be taken at Treatment Period 2. The samples are to be taken consectively at following moments: 120, 219: Predose 121, 220: 0 - 6 hr 122, 221: 6 - 12 hr 123, 222: 12 - 24 hr 124, 223: 24 - 48 hr 125, 224: 48 - 72 hr 126, 225: 72 - 96 hr 127, 226: 96 - 120 hr 128, 227: 120 - 144 hr 129, 228: 144 - 168 hr 130, 229: 168 - 192 hr 131, 230: 192 - 216 hr

Datentyp

integer

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C1299222
Metabolite Profiling - Faeces
Beschreibung

Metabolite Profiling - Faeces

Alias
UMLS CUI-1
C0005507
UMLS CUI-2
C0870883
UMLS CUI-3
C0015733
Planned Relative Time Interval
Beschreibung

Stool sample collection Planned Relative Time Interval

Datentyp

text

Alias
UMLS CUI [1,1]
C0455051
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1272706
UMLS CUI [1,4]
C1301732
Start Date
Beschreibung

Stool sample collection Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0455051
UMLS CUI [1,2]
C0808070
Actual Start Time
Beschreibung

Stool sample collection Actual Start Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0455051
UMLS CUI [1,2]
C1301880
Stop Date
Beschreibung

Stool sample collection Stop Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0455051
UMLS CUI [1,2]
C0806020
Actual Stop Time
Beschreibung

Stool sample collection Actual Stop Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0455051
UMLS CUI [1,2]
C1522314
Was all of the sample collected for this interval?
Beschreibung

Stool sample collection: Was all of the sample collected for this interval?

Datentyp

text

Alias
UMLS CUI [1,1]
C0455051
UMLS CUI [1,2]
C0205197
Sample Number
Beschreibung

The samples numbered 1xx are to be taken at Treatment Period 1. The samples numbered 2xx are to be taken at Treatment Period 2. The samples are to be taken consectively at following moments: 132, 231: Predose (if available) 133, 232: 0 - 24 hr 134, 233: 24 - 48 hr 135, 234: 48 - 72 hr 136, 235: 72 - 96 hr 137, 236: 96 - 120 hr 138, 237: 120 - 144 hr 139, 238: 144 - 168 hr 140, 239: 168 - 192 hr 141, 240: 192 - 216 hr 142: 216 - 240 hr 143: 240 - 264 hr 144: 264 - 432 hr

Datentyp

integer

Alias
UMLS CUI [1,1]
C0455051
UMLS CUI [1,2]
C1299222
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Ähnliche Modelle

Pharmacokinetics – blood; Metabolite profiling – plasma, Urine, Faeces

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
Visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit Type
Code List
Visit Type
CL Item
Treatment Period 1 (Treatment Period 1)
CL Item
Treatment Period 2 (Treatment Period 2)
Item Group
Pharmacokinetics - Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
text
C0005834 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Predose (Predose)
CL Item
0.25 hr (immediately post-infusion) (0.25 hr (immediately post-infusion))
CL Item
0.5 hr (0.5 hr)
CL Item
1 hr (1 hr)
CL Item
2 hr (2 hr)
CL Item
3 hr (3 hr)
CL Item
4 hr (4 hr)
CL Item
6 hr (6 hr)
CL Item
10 hr (10 hr)
CL Item
16 hr (16 hr)
CL Item
24 hr (24 hr)
CL Item
36 hr (36 hr)
CL Item
48 hr (48 hr)
CL Item
72 hr (72 hr)
Blood sample Scheduled Time
Item
Scheduled Time
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Blood sample Date Sample Taken
Item
Date Sample Taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Blood sample Actual Time
Item
Actual Time
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Blood sample Taken
Item
7 mL Sample Check Yes if taken
boolean
C0005834 (UMLS CUI [1,1])
C1883727 (UMLS CUI [1,2])
Item
Sample Number
integer
C0005834 (UMLS CUI [1,1])
C1299222 (UMLS CUI [1,2])
Sample Number
Code List
Sample Number
CL Item
101 (101)
CL Item
102 (120)
CL Item
103 (103)
CL Item
104 (104)
CL Item
105 (105)
CL Item
106 (106)
CL Item
107 (107)
CL Item
108 (108)
CL Item
109 (109)
CL Item
110 (110)
CL Item
111 (111)
CL Item
112 (112)
CL Item
113 (113)
CL Item
114 (114)
CL Item
201 (201)
CL Item
202 (202)
CL Item
203 (203)
CL Item
204 (204)
CL Item
205 (205)
CL Item
206 (206)
CL Item
207 (207)
CL Item
208 (208)
CL Item
209 (209)
CL Item
210 (210)
CL Item
211 (211)
CL Item
212 (212)
CL Item
213 (213)
Item Group
Metabolite Profiling - Plasma
C0005507 (UMLS CUI-1)
C0870883 (UMLS CUI-2)
C0032105 (UMLS CUI-3)
Item
Planned Relative Time
text
C0032105 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Predose (Predose)
(Comment:en)
CL Item
0.25 hr (0.25 hr)
(Comment:en)
CL Item
1 hr (1 hr)
(Comment:en)
CL Item
3 hr (3 hr)
(Comment:en)
CL Item
6 hr (6 hr)
(Comment:en)
CL Item
16 hr (16 hr)
Plasma sample collection Scheduled Time
Item
Scheduled Time
time
C0032105 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Plasma sample collection Date Sample Taken
Item
Date Sample Taken
date
C0032105 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Plasma sample collection Actual Time
Item
Actual Time
time
C0032105 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Plasma sample collection Taken
Item
30 mL Sample Check Yes if taken
boolean
C0032105 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,3])
Item
Sample Number
integer
C0032105 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
Sample Number
Code List
Sample Number
CL Item
115 (115)
CL Item
116 (116)
CL Item
117 (117)
CL Item
118 (118)
CL Item
119 (119)
CL Item
214 (214)
CL Item
215 (215)
CL Item
216 (216)
CL Item
217 (217)
CL Item
218 (218)
Item Group
Metabolite Profiling - Urine
C0005507 (UMLS CUI-1)
C0870883 (UMLS CUI-2)
C0042036 (UMLS CUI-3)
Item
Planned Relative Time Interval
text
C0200354 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1272706 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Urine sample collection Planned Relative Time Interval
Code List
Planned Relative Time Interval
CL Item
Predose (Predose)
CL Item
0 - 6 hr (0 - 6 hr)
CL Item
6 - 12 hr (6 - 12 hr)
CL Item
12 - 24 hr (12 - 24 hr)
CL Item
24 - 48 hr (24 - 48 hr)
CL Item
48 - 72 hr (48 - 72 hr)
CL Item
72 - 96 hr (72 - 96 hr)
CL Item
96 - 120 hr (96 - 120 hr)
CL Item
120 - 144 hr (120 - 144 hr)
CL Item
144 - 168 hr (144 - 168 hr)
CL Item
168 - 192 hr (168 - 192 hr)
CL Item
192 - 216 hr (192 - 216 hr)
Urine sample collection Start Date
Item
Start Date
date
C0200354 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Urine sample collection Actual Start Time
Item
Actual Start Time
time
C0200354 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Urine sample collection Stop Date
Item
Stop Date
date
C0200354 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Urine sample collection Actual Stop Time
Item
Actual Stop Time
time
C0200354 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Was all of the sample collected for this interval?
text
C0200354 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Urine sample collection: Was all of the sample collected for this interval?
Code List
Was all of the sample collected for this interval?
CL Item
Yes (Y)
CL Item
No (N)
Item
Sample Number
integer
C0200354 (UMLS CUI [1,1])
C1299222 (UMLS CUI [1,2])
Urine sample collection Sample Number
Code List
Sample Number
CL Item
120 (120)
CL Item
121 (121)
CL Item
122 (122)
CL Item
123 (123)
CL Item
124 (124)
CL Item
125 (125)
CL Item
126 (126)
CL Item
127 (127)
CL Item
128 (128)
CL Item
129 (129)
CL Item
130 (130)
CL Item
131 (131)
CL Item
219 (219)
CL Item
220 (220)
CL Item
221 (221)
CL Item
222 (222)
CL Item
223 (223)
CL Item
224 (224)
CL Item
225 (225)
CL Item
226 (226)
CL Item
227 (227)
CL Item
228 (228)
CL Item
229 (229)
CL Item
230 (230)
Item Group
Metabolite Profiling - Faeces
C0005507 (UMLS CUI-1)
C0870883 (UMLS CUI-2)
C0015733 (UMLS CUI-3)
Item
Planned Relative Time Interval
text
C0455051 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1272706 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Stool sample collection Planned Relative Time Interval
Code List
Planned Relative Time Interval
CL Item
Predose (if available) (Predose (if available))
CL Item
0 - 24 hr (0 - 24 hr)
CL Item
24 - 48 hr (24 - 48 hr)
CL Item
48 - 72 hr (48 - 72 hr)
CL Item
72 - 96 hr (72 - 96 hr)
CL Item
96 - 120 hr (96 - 120 hr)
CL Item
120 - 144 hr (120 - 144 hr)
CL Item
144 - 168 hr (144 - 168 hr)
CL Item
168 - 192 hr (168 - 192 hr)
CL Item
192 - 216 hr (192 - 216 hr)
CL Item
216 - 240 hr (216 - 240 hr)
CL Item
240 - 264 hr (240 - 264 hr)
CL Item
264 - 432 hr (264 - 432 hr)
Stool sample collection Start Date
Item
Start Date
date
C0455051 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Stool sample collection Actual Start Time
Item
Actual Start Time
time
C0455051 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Stool sample collection Stop Date
Item
Stop Date
date
C0455051 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Stool sample collection Actual Stop Time
Item
Actual Stop Time
time
C0455051 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Stool sample collection: Was all of the sample collected for this interval?
Item
Was all of the sample collected for this interval?
text
C0455051 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item
Sample Number
integer
C0455051 (UMLS CUI [1,1])
C1299222 (UMLS CUI [1,2])
Stool sample collection Sample Number
Code List
Sample Number
CL Item
132 (132)
CL Item
133 (133)
CL Item
134 (134)
CL Item
135 (135)
CL Item
136 (136)
CL Item
137 (137)
CL Item
138 (138)
CL Item
139 (139)
CL Item
140 (140)
CL Item
141 (141)
CL Item
142 (142)
CL Item
143 (143)
CL Item
144 (144)
CL Item
231 (231)
CL Item
232 (232)
CL Item
233 (233)
CL Item
234 (234)
CL Item
235 (235)
CL Item
236 (236)
CL Item
237 (237)
CL Item
238 (238)
CL Item
239 (239)
CL Item
240 (240)
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