ID

33284

Beschrijving

Study ID: 107806 Clinical Study ID: RA3107806 Study Title: An open label study to determine the safety, tolerability, excretion balance and pharmacokinetics of Losmapimod, administered as a single dose of an oral solution to healthy adult male subjects Patient Level Data: Clinicaltrials.gov Identifier: NCT00599612 https://clinicaltrials.gov/ct2/show/NCT00599612 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: losmapimod Trade Name: losmapimod Study Indication: Pulmonary Disease, Chronic Obstructive The study consists of a screening, study visit and follow-up. The protocol identifier for all: RA3107806 This document contains the Pharmacokinetics - Blood form (cold analysis, metabolites, plasma radioactivity, sampling urine interval collection data, sampling faeces interval collection data). It has to be filled in for study visit.

Link

https://clinicaltrials.gov/ct2/show/NCT00599612

Trefwoorden

Versies (2)
  1. 03-12-18 03-12-18 -
  2. 04-12-18 04-12-18 -
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GlaxoSmithKline

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4 december 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612

Engels

Pharmacokinetics(cold analysis, metabolites, plasma radioactivity, sampling urine interval collection data, sampling faeces interval collection data)

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Beschrijving

Subject identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Pharmacokinetics - Blood (cold analysis)
Beschrijving

Pharmacokinetics - Blood (cold analysis)

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C0005767
UMLS CUI-3
C0936012
Planned Relative Time
Beschrijving

Time Relative to Dosing

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1]
C0040223
Sample Taken
Beschrijving

Tick if taken

Datatype

boolean

Alias
UMLS CUI [1]
C1277698
Sample Number
Beschrijving

Sample Number

Datatype

text

Alias
UMLS CUI [1]
C1299222
Pharmacokinetics - Blood (metabolites)
Beschrijving

Pharmacokinetics - Blood (metabolites)

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C0005767
UMLS CUI-3
C0870883
Planned Relative Time
Beschrijving

Time Relative to Dosing

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1]
C0040223
Sample Taken
Beschrijving

Tick if taken

Datatype

boolean

Alias
UMLS CUI [1]
C1277698
Sample Number
Beschrijving

Sample Number

Datatype

text

Alias
UMLS CUI [1]
C1299222
Pharmacokinetics - Blood (plasma radioactivity)
Beschrijving

Pharmacokinetics - Blood (plasma radioactivity)

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C0005767
UMLS CUI-3
C0032105
UMLS CUI-4
C0034553
Planned Relative Time
Beschrijving

Time Relative to Dosing

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C1302413
Actual Start Time
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1]
C0040223
Sample Taken
Beschrijving

Tick if taken

Datatype

boolean

Alias
UMLS CUI [1]
C1277698
Sample Number
Beschrijving

Sample Number

Datatype

text

Alias
UMLS CUI [1]
C1299222
Pharmacokinetics sampling urine interval collection data
Beschrijving

Pharmacokinetics sampling urine interval collection data

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C0200354
Planned Relative Time
Beschrijving

Time Relative to Dosing

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Start Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C0808070
Actual Start Time
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1]
C0040223
Stop Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C0806020
Actual Stop Time
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1]
C1522314
Was all of the sample collected for this intervall?
Beschrijving

Sample collection

Datatype

text

Alias
UMLS CUI [1]
C0200345
Sample Taken
Beschrijving

Tick if taken

Datatype

boolean

Alias
UMLS CUI [1]
C1277698
Sample Number
Beschrijving

Sample Number

Datatype

text

Alias
UMLS CUI [1]
C1299222
Pharmacokinetics sampling faeces interval collection data
Beschrijving

Pharmacokinetics sampling faeces interval collection data

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C0015733
Planned Relative Time
Beschrijving

Time Relative to Dosing

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Start Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C0808070
Actual Start Time
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1]
C0040223
Stop Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C0806020
Actual Stop Time
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1]
C1522314
Was all of the sample collected for this intervall?
Beschrijving

Sample collection

Datatype

text

Alias
UMLS CUI [1]
C0200345
Sample Taken
Beschrijving

Tick if taken

Datatype

boolean

Alias
UMLS CUI [1]
C1277698
Sample Number
Beschrijving

Sample Number

Datatype

text

Alias
UMLS CUI [1]
C1299222
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Similar models

Pharmacokinetics(cold analysis, metabolites, plasma radioactivity, sampling urine interval collection data, sampling faeces interval collection data)

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Item Group
Pharmacokinetics - Blood (cold analysis)
C0031327 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0936012 (UMLS CUI-3)
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
0.5 hrs (2)
CL Item
1 hr (3)
CL Item
1.5 hrs (4)
CL Item
2 hrs (5)
CL Item
3 hrs (6)
CL Item
4 hrs (7)
CL Item
6 hrs (8)
CL Item
8 hrs (9)
CL Item
12 hrs (10)
CL Item
24 hrs (11)
CL Item
36 hrs (12)
CL Item
48 hrs (13)
CL Item
72 hrs (14)
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Sample Taken
Item
Sample Taken
boolean
C1277698 (UMLS CUI [1])
Item
Sample Number
text
C1299222 (UMLS CUI [1])
Sample Number
Code List
Sample Number
CL Item
101 (Pre-dose)
CL Item
102 (0.5 hrs)
CL Item
103 (1 hr)
CL Item
104 (1.5 hrs)
CL Item
105 (2 hrs)
CL Item
106 (3 hrs)
CL Item
107 (4 hrs)
CL Item
108 (6 hrs)
CL Item
109 (8 hrs)
CL Item
110 (12 hrs)
CL Item
111 (24 hrs)
CL Item
112 (36 hrs)
CL Item
113 (48 hrs)
CL Item
114 (72 hrs)
Item Group
Pharmacokinetics - Blood (metabolites)
C0031327 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0870883 (UMLS CUI-3)
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
1 hr (2)
CL Item
4 hrs (3)
CL Item
12 hrs (4)
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Sample Taken
Item
Sample Taken
boolean
C1277698 (UMLS CUI [1])
Item
Sample Number
text
C1299222 (UMLS CUI [1])
Sample Number
Code List
Sample Number
CL Item
115 (Pre-dose)
CL Item
116 (1 hr)
CL Item
117 (4 hrs)
CL Item
118 (12 hrs)
Item Group
Pharmacokinetics - Blood (plasma radioactivity)
C0031327 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0032105 (UMLS CUI-3)
C0034553 (UMLS CUI-4)
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
0.5 hrs (2)
CL Item
1 hr (3)
CL Item
1.5 hrs (4)
CL Item
2 hrs (5)
CL Item
3 hrs (6)
CL Item
4 hrs (7)
CL Item
6 hrs (8)
CL Item
8 hrs (9)
CL Item
12 hrs (10)
CL Item
24 hrs (11)
CL Item
36 hrs (12)
CL Item
48 hrs (13)
CL Item
72 hrs (14)
CL Item
96 hrs (15)
CL Item
120 hrs (16)
CL Item
144 hrs (17)
CL Item
168 hrs (18)
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Actual Start Time
Item
Actual Start Time
time
C0040223 (UMLS CUI [1])
Sample Taken
Item
Sample Taken
boolean
C1277698 (UMLS CUI [1])
Item
Sample Number
text
C1299222 (UMLS CUI [1])
Sample Number
Code List
Sample Number
CL Item
119 (Pre-dose)
CL Item
120 (0.5 hrs)
CL Item
121 (1 hr)
CL Item
122 (1.5 hrs)
CL Item
123 (2 hrs)
CL Item
124 (3 hrs)
CL Item
125 (4 hrs)
CL Item
126 (6 hrs)
CL Item
127 (8 hrs)
CL Item
128 (12 hrs)
CL Item
129 (24 hrs)
CL Item
130 (36 hrs)
CL Item
131 (48 hrs)
CL Item
132 (72 hrs)
CL Item
133 (96 hrs)
CL Item
134 (120 hrs)
CL Item
135 (144 hrs)
CL Item
136 (168 hrs)
Item Group
Pharmacokinetics sampling urine interval collection data
C0031327 (UMLS CUI-1)
C0200354 (UMLS CUI-2)
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
0-6 hrs (2)
CL Item
6-12 hrs (3)
CL Item
12-24 hrs (4)
CL Item
24-48 hrs (5)
CL Item
48-72hrs (6)
CL Item
72-96 hrs (7)
CL Item
96-120 hrs (8)
CL Item
120-144 hrs (9)
CL Item
144-168 hrs (10)
CL Item
168-192 hrs (11)
CL Item
192-216 hrs (12)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Actual Start Time
Item
Actual Start Time
time
C0040223 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Actual Stop Time
Item
Actual Stop Time
time
C1522314 (UMLS CUI [1])
Item
Was all of the sample collected for this intervall?
text
C0200345 (UMLS CUI [1])
Sample collection
Code List
Was all of the sample collected for this intervall?
CL Item
Yes (Y)
CL Item
No (N)
Sample Taken
Item
Sample Taken
boolean
C1277698 (UMLS CUI [1])
Item
Sample Number
text
C1299222 (UMLS CUI [1])
Sample Number
Code List
Sample Number
CL Item
137 (Pre-dose)
CL Item
138 (0-6 hrs)
CL Item
139 (6-12 hrs)
CL Item
140 (12-24 hrs)
CL Item
141 (24-48 hrs)
CL Item
142 (48-72hrs)
CL Item
143  (72-96 hrs)
CL Item
144 (96-120 hrs)
CL Item
145 (120-144 hrs)
CL Item
146 (144-168 hrs)
CL Item
147  (168-192 hrs)
CL Item
148 (192-216 hrs)
Item Group
Pharmacokinetics sampling faeces interval collection data
C0031327 (UMLS CUI-1)
C0015733 (UMLS CUI-2)
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
0-6 hrs (2)
CL Item
6-12 hrs (3)
CL Item
12-24 hrs (4)
CL Item
24-48 hrs (5)
CL Item
48-72hrs (6)
CL Item
72-96 hrs (7)
CL Item
96-120 hrs (8)
CL Item
120-144 hrs (9)
CL Item
144-168 hrs (10)
CL Item
168-192 hrs (11)
CL Item
192-216 hrs (12)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Actual Start Time
Item
Actual Start Time
time
C0040223 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Actual Stop Time
Item
Actual Stop Time
time
C1522314 (UMLS CUI [1])
Item
Was all of the sample collected for this intervall?
text
C0200345 (UMLS CUI [1])
Sample collection
Code List
Was all of the sample collected for this intervall?
CL Item
Yes (Y)
CL Item
No (N)
Sample Taken
Item
Sample Taken
boolean
C1277698 (UMLS CUI [1])
Item
Sample Number
text
C1299222 (UMLS CUI [1])
Sample Number
Code List
Sample Number
CL Item
149 (Pre-dose)
CL Item
150 (0-6 hrs)
CL Item
151 (6-12 hrs)
CL Item
152 (12-24 hrs)
CL Item
153 (24-48 hrs)
CL Item
154 (48-72hrs)
CL Item
155 (72-96 hrs)
CL Item
156  (96-120 hrs)
CL Item
157 (120-144 hrs)
CL Item
158 (144-168 hrs)
CL Item
159 (168-192 hrs)
CL Item
160 (192-216 hrs)
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