ID

38810

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. 11/5/19 11/5/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 5, 2019

DOI

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License

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

Investigational Product (Period 1 - 5; Day 1 - Day 16)

1 forms  
Investigational Product (Dose) (Period 1 - 5)
Description

Investigational Product (Dose) (Period 1 - 5)

Date/ time of dose
Description

Date/ time of dose

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0011008
Number of Actuations
Description

Number of Actuations

Data type

integer

Alias
UMLS CUI [1]
C4055499
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Description

Did the subject receive the correct treatment during this dosing interval?

Data type

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
If the subject did not receive the correct treatment during this dosing interval, record reasons.
Description

If the subject did not receive the correct treatment during this dosing interval, record reasons.

Data type

text

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0392360
Investigational Product (Dose) (Day 1 - 13)
Description

Investigational Product (Dose) (Day 1 - 13)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
Dose Timepoint
Description

Dose Timepoint

Data type

integer

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C2348792
Start date/time of dose
Description

Start date/time of dose

Data type

datetime

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C1301880
UMLS CUI [2,2]
C0178602
Number of Actuations
Description

Number of Actuations

Data type

integer

Alias
UMLS CUI [1]
C4055499
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Description

Did the subject receive the correct treatment during this dosing interval?

Data type

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
If the subject did not receive the correct treatment during this dosing interval, record reasons.
Description

If the subject did not receive the correct treatment during this dosing interval, record reasons.

Data type

text

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0392360
Investigational Product (Day 3 - Day 13 Dose)
Description

Investigational Product (Day 3 - Day 13 Dose)

Alias
UMLS CUI-1
C0304229
Dose Timepoint
Description

Dose Timepoint

Data type

integer

Alias
UMLS CUI [1,1]
C2348792
UMLS CUI [1,2]
C2348792
Start date/time of dose
Description

Start date/time of dose

Data type

datetime

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C1301880
UMLS CUI [2,2]
C0178602
Number of Actuations
Description

Number of Actuations

Data type

integer

Alias
UMLS CUI [1]
C4055499
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Description

Did the subject receive the correct treatment during this dosing interval?

Data type

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
If the subject did not receive the correct treatment during this dosing interval, record reasons.
Description

If the subject did not receive the correct treatment during this dosing interval, record reasons.

Data type

text

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0392360
Investigational Product (Dose) (Day 14 - 16)
Description

Investigational Product (Dose) (Day 14 - 16)

Alias
UMLS CUI-1
C0304229
Dose Timepoint
Description

Dose Timepoint

Data type

integer

Alias
UMLS CUI [1,1]
C2348792
UMLS CUI [1,2]
C2348792
Start date/time of dose
Description

Start date/time of dose

Data type

datetime

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C1301880
UMLS CUI [2,2]
C0178602
Number of Actuations
Description

Number of Actuations

Data type

integer

Alias
UMLS CUI [1]
C4055499
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Description

Did the subject receive the correct treatment during this dosing interval?

Data type

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
If the subject did not receive the correct treatment during this dosing interval, record reasons.
Description

If the subject did not receive the correct treatment during this dosing interval, record reasons.

Data type

text

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0392360
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Similar models

Investigational Product (Period 1 - 5; Day 1 - Day 16)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Investigational Product (Dose) (Period 1 - 5)
Date/ time of dose
Item
Date/ time of dose
datetime
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Number of Actuations
Item
Number of Actuations
integer
C4055499 (UMLS CUI [1])
Did the subject receive the correct treatment during this dosing interval?
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
If the subject did not receive the correct treatment during this dosing interval, record reasons.
Item
If the subject did not receive the correct treatment during this dosing interval, record reasons.
text
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item Group
Investigational Product (Dose) (Day 1 - 13)
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
Item
Dose Timepoint
integer
C0178602 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Dose Timepoint
Code List
Dose Timepoint
CL Item
Day 1 AM dose (1)
CL Item
Day 1 PM dose (2)
CL Item
Day 2 AM dose (3)
CL Item
Day 2 PM dose (4)
Start date/time of dose
Item
Start date/time of dose
datetime
C0808070 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1301880 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Number of Actuations
Item
Number of Actuations
integer
C4055499 (UMLS CUI [1])
Did the subject receive the correct treatment during this dosing interval?
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
If the subject did not receive the correct treatment during this dosing interval, record reasons.
Item
If the subject did not receive the correct treatment during this dosing interval, record reasons.
text
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item Group
Investigational Product (Day 3 - Day 13 Dose)
C0304229 (UMLS CUI-1)
Item
Dose Timepoint
integer
C2348792 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Timepoint
Code List
Dose Timepoint
CL Item
Day 3 AM (1)
CL Item
Day 3 PM (2)
CL Item
Day 4 AM (3)
CL Item
Day 4 PM (4)
CL Item
Day 5 AM (5)
CL Item
Day 5 PM (6)
CL Item
Day 6 AM (7)
CL Item
Day 6 PM (8)
CL Item
Day 7 AM (9)
CL Item
Day 7 PM (10)
CL Item
Day 8 AM (11)
CL Item
Day 8 PM (12)
CL Item
Day 9 AM (13)
CL Item
Day 9 PM (14)
CL Item
Day 10 AM (15)
CL Item
Day 10 PM (16)
CL Item
Day 11 AM (17)
CL Item
Day 11PM (18)
CL Item
Day 12 AM (19)
CL Item
Day 12 PM (20)
CL Item
Day 13 AM (21)
CL Item
Day 13 PM (22)
Start date/time of dose
Item
Start date/time of dose
datetime
C0808070 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1301880 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Number of Actuations
Item
Number of Actuations
integer
C4055499 (UMLS CUI [1])
Did the subject receive the correct treatment during this dosing interval?
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
If the subject did not receive the correct treatment during this dosing interval, record reasons.
Item
If the subject did not receive the correct treatment during this dosing interval, record reasons.
text
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item Group
Investigational Product (Dose) (Day 14 - 16)
C0304229 (UMLS CUI-1)
Item
Dose Timepoint
integer
C2348792 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Dose Timepoint
Code List
Dose Timepoint
CL Item
Day 14 AM dose (1)
CL Item
Day 14 PM dose (2)
Start date/time of dose
Item
Start date/time of dose
datetime
C0808070 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1301880 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Number of Actuations
Item
Number of Actuations
integer
C4055499 (UMLS CUI [1])
Did the subject receive the correct treatment during this dosing interval?
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
If the subject did not receive the correct treatment during this dosing interval, record reasons.
Item
If the subject did not receive the correct treatment during this dosing interval, record reasons.
text
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
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