ID
40846
Description
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.
Mots-clés
Versions (1)
- 24/05/2020 24/05/2020 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
24 mai 2020
DOI
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Licence
Creative Commons BY-NC 4.0
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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933
Pharmacokinetics – blood; Metabolite profiling – plasma, Urine, Faeces
Description
Pharmacokinetics - Blood
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005767
Description
0.25 hr (immediately post-infusion) sample to be taken only in Treatment Period 1.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
Description
Blood sample Scheduled Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C1301732
Description
Blood sample Date Sample Taken
Type de données
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Description
Blood sample Actual Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0040223
Description
Blood sample Taken
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C1883727
Description
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
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C1299222
Description
Metabolite Profiling - Plasma
Alias
- UMLS CUI-1
- C0005507
- UMLS CUI-2
- C0870883
- UMLS CUI-3
- C0032105
Description
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.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0032105
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0439564
- UMLS CUI [1,4]
- C1301732
Description
Plasma sample collection Scheduled Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C0032105
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0040223
- UMLS CUI [1,4]
- C1301732
Description
Plasma sample collection Date Sample Taken
Type de données
date
Alias
- UMLS CUI [1,1]
- C0032105
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0011008
Description
Plasma sample collection Actual Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C0032105
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0040223
Description
Plasma sample collection Taken
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0032105
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1883727
Description
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
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0032105
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C1299222
Description
Metabolite Profiling - Urine
Alias
- UMLS CUI-1
- C0005507
- UMLS CUI-2
- C0870883
- UMLS CUI-3
- C0042036
Description
Urine sample collection Planned Relative Time Interval
Type de données
text
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1272706
- UMLS CUI [1,4]
- C1301732
Description
Urine sample collection Start Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C0808070
Description
Urine sample collection Actual Start Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C1301880
Description
Urine sample collection Stop Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C0806020
Description
Urine sample collection Actual Stop Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C1522314
Description
Urine sample collection: Was all of the sample collected for this interval?
Type de données
text
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C0205197
Description
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
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C1299222
Description
Metabolite Profiling - Faeces
Alias
- UMLS CUI-1
- C0005507
- UMLS CUI-2
- C0870883
- UMLS CUI-3
- C0015733
Description
Stool sample collection Planned Relative Time Interval
Type de données
text
Alias
- UMLS CUI [1,1]
- C0455051
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1272706
- UMLS CUI [1,4]
- C1301732
Description
Stool sample collection Start Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0455051
- UMLS CUI [1,2]
- C0808070
Description
Stool sample collection Actual Start Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C0455051
- UMLS CUI [1,2]
- C1301880
Description
Stool sample collection Stop Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0455051
- UMLS CUI [1,2]
- C0806020
Description
Stool sample collection Actual Stop Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C0455051
- UMLS CUI [1,2]
- C1522314
Description
Stool sample collection: Was all of the sample collected for this interval?
Type de données
text
Alias
- UMLS CUI [1,1]
- C0455051
- UMLS CUI [1,2]
- C0205197
Description
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
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0455051
- UMLS CUI [1,2]
- C1299222
Similar models
Pharmacokinetics – blood; Metabolite profiling – plasma, Urine, Faeces
C0005767 (UMLS CUI-2)
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,2])
C0870883 (UMLS CUI-2)
C0032105 (UMLS CUI-3)
C0200345 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
C0870883 (UMLS CUI-2)
C0042036 (UMLS CUI-3)
C0439564 (UMLS CUI [1,2])
C1272706 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,2])
C0870883 (UMLS CUI-2)
C0015733 (UMLS CUI-3)
C0439564 (UMLS CUI [1,2])
C1272706 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,2])