ID

38820

Description

Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

Keywords

Versions (1)
  1. 11/6/19 11/6/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 6, 2019

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Creative Commons BY-NC 3.0
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Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933

English

Pharmacokinetics Blood (Period 1 - 5; Day 1 - Day 16)

1 forms  
Pharmacokinetics Blood - Dosing date and time (Period 1 - 5)
Description

Pharmacokinetics Blood - Dosing date and time (Period 1 - 5)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
UMLS CUI-3
C0178602
UMLS CUI-4
C1264639
Dosing date and time
Description

Dosing date and time

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
Repeat Pharmacokinetics Blood (Period 1 - 5)
Description

Repeat Pharmacokinetics Blood (Period 1 - 5)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
UMLS CUI-3
C0205341
Actual date/time
Description

Actual date/time

Data type

datetime

Alias
UMLS CUI [1]
C1264639
Timepoint
Description

Timepoint

Data type

integer

Alias
UMLS CUI [1]
C2348792
Pharmacokinetics Blood - Dosing date and time (Day 1 - 13)
Description

Pharmacokinetics Blood - Dosing date and time (Day 1 - 13)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
AM Dosing date and time
Description

AM Dosing date and time

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [1,3]
C4331833
PM Dosing date and time
Description

PM Dosing date and time

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [1,3]
C1509133
Pharmacokinetics Blood (Day 1 - 13)
Description

Pharmacokinetics Blood (Day 1 - 13)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Timepoint
Description

Timepoint

Data type

integer

Alias
UMLS CUI [1]
C2348792
Actual date/time
Description

Actual date/time

Data type

datetime

Alias
UMLS CUI [1]
C1264639
Pharmacokinetics Blood - Dosing date and time (Day 14 - 16)
Description

Pharmacokinetics Blood - Dosing date and time (Day 14 - 16)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
AM Dosing date and time
Description

AM Dosing date and time

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
PM Dosing date and time
Description

PM Dosing date and time

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
UMLS CUI [1,3]
C1509133
Pharmacokinetics Blood (Day 14 - 16)
Description

Pharmacokinetics Blood (Day 14 - 16)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Timepoint
Description

Timepoint

Data type

integer

Alias
UMLS CUI [1]
C2348792
Actual date/time
Description

Actual date/time

Data type

datetime

Alias
UMLS CUI [1]
C1264639
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Similar models

Pharmacokinetics Blood (Period 1 - 5; Day 1 - Day 16)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Pharmacokinetics Blood - Dosing date and time (Period 1 - 5)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0178602 (UMLS CUI-3)
C1264639 (UMLS CUI-4)
Dosing date and time
Item
Dosing date and time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item Group
Repeat Pharmacokinetics Blood (Period 1 - 5)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
Actual date/time
Item
Actual date/time
datetime
C1264639 (UMLS CUI [1])
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Timepoint
Code List
Timepoint
CL Item
Pre dose (1)
CL Item
15 mins (2)
CL Item
30 mins (3)
CL Item
1 hr (4)
CL Item
2 hr (5)
CL Item
4 hr (6)
CL Item
8 hr (7)
CL Item
12 hr (8)
CL Item
24 hr (9)
Item Group
Pharmacokinetics Blood - Dosing date and time (Day 1 - 13)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
AM Dosing date and time
Item
AM Dosing date and time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C4331833 (UMLS CUI [1,3])
PM Dosing date and time
Item
PM Dosing date and time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1509133 (UMLS CUI [1,3])
Item Group
Pharmacokinetics Blood (Day 1 - 13)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Timepoint
Code List
Timepoint
CL Item
Pre dose (1)
CL Item
15 mins (2)
CL Item
30 mins (3)
CL Item
1 hr (4)
CL Item
2 hr (5)
CL Item
4 hr (6)
CL Item
8 hr (7)
CL Item
12 hr (8)
CL Item
12 hr:15 mins (9)
CL Item
12 hr: 30 mins (10)
CL Item
13 hr (11)
CL Item
14 hr (12)
CL Item
16 hr (13)
CL Item
20 hr (14)
CL Item
24 hr (15)
CL Item
36 hr (16)
Actual date/time
Item
Actual date/time
datetime
C1264639 (UMLS CUI [1])
Item Group
Pharmacokinetics Blood - Dosing date and time (Day 14 - 16)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
AM Dosing date and time
Item
AM Dosing date and time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
PM Dosing date and time
Item
PM Dosing date and time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1509133 (UMLS CUI [1,3])
Item Group
Pharmacokinetics Blood (Day 14 - 16)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Timepoint
Code List
Timepoint
CL Item
Pre dose (1)
CL Item
15 mins (2)
CL Item
30 mins (3)
CL Item
1 hr (4)
CL Item
2 hr (5)
CL Item
4 hr (6)
CL Item
8 hr (7)
CL Item
12 hr (8)
CL Item
12 hr:15 mins (9)
CL Item
12 hr:30 mins (10)
CL Item
13 hr (11)
CL Item
14 hr (12)
CL Item
16 hr (13)
CL Item
20 hr (14)
CL Item
24 hr (15)
CL Item
36 hr (16)
CL Item
48 hr (17)
CL Item
60 hr (18)
Actual date/time
Item
Actual date/time
datetime
C1264639 (UMLS CUI [1])
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