0 Evaluaciones
ID

40846

Descripción

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.

Palabras clave

Versiones (1)
  1. 24/5/20 24/5/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

24 de mayo de 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

    Inglés

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

    1 formularios  
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Descripción

    Subject Identifier

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Descripción

    Visit Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303
    Visit Type
    Descripción

    Visit Type

    Tipo de datos

    text

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

    Pharmacokinetics - Blood

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

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

    Tipo de datos

    text

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

    Blood sample Scheduled Time

    Tipo de datos

    time

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

    Blood sample Date Sample Taken

    Tipo de datos

    date

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

    Blood sample Actual Time

    Tipo de datos

    time

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

    Blood sample Taken

    Tipo de datos

    boolean

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

    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

    Tipo de datos

    integer

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

    Metabolite Profiling - Plasma

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

    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.

    Tipo de datos

    text

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

    Plasma sample collection Scheduled Time

    Tipo de datos

    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
    Descripción

    Plasma sample collection Date Sample Taken

    Tipo de datos

    date

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

    Plasma sample collection Actual Time

    Tipo de datos

    time

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

    Plasma sample collection Taken

    Tipo de datos

    boolean

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

    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

    Tipo de datos

    integer

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

    Metabolite Profiling - Urine

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

    Urine sample collection Planned Relative Time Interval

    Tipo de datos

    text

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

    Urine sample collection Start Date

    Tipo de datos

    date

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

    Urine sample collection Actual Start Time

    Tipo de datos

    time

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

    Urine sample collection Stop Date

    Tipo de datos

    date

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

    Urine sample collection Actual Stop Time

    Tipo de datos

    time

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

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

    Tipo de datos

    text

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

    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

    Tipo de datos

    integer

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

    Metabolite Profiling - Faeces

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

    Stool sample collection Planned Relative Time Interval

    Tipo de datos

    text

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

    Stool sample collection Start Date

    Tipo de datos

    date

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

    Stool sample collection Actual Start Time

    Tipo de datos

    time

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

    Stool sample collection Stop Date

    Tipo de datos

    date

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

    Stool sample collection Actual Stop Time

    Tipo de datos

    time

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

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

    Tipo de datos

    text

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

    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

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0455051
    UMLS CUI [1,2]
    C1299222
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    Similar models

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

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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
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