ID

38180

Beskrivning

Study ID: 110951 Clinical Study ID: 110951 Study Title: A two-part, randomised, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of intravenously infused GSK1995057 in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01476046 See https://clinicaltrials.gov/ct2/show/NCT01476046 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: N/A, Placebo Trade Name: N/A Study Indication: Respiratory Disorders The single-centre study consists of two parts A and B with seven cohorts/ten subcohorts in total. Part A includes ascending doses of the investigational product given to subjects negative or positive for pre-existing human anti-heavy chain variable domain (HAVH) antibodies (Cohorts 1 to 3 with Subcohorts 1a, 2a and 3a negative for HAVH and 1b, 2b, 3b positive for HAVH). Part B includes only subjects negative for HAVH, with ascending doses given to Cohorts 4 to 6. Cohort 7 receives the same dose as Cohort 6, but whereas the other Cohorts are single-blinded, Cohort 7 is open-label and additionally receives a bronchoalveolar lavage (BAL). The study consists of a Screening Visit (up to 56 days before Day 1, the day of the drug administration), Visits on Day -1, 1, 2, 3, 5, 7, 14, 28 and Follow-Up Visits on Day 57 and 85. This form contains information on the 12 lead ECG, which is recorded at Screening, on Days 1, 3, 5, 7, 14, 28, in case of early withdrawal and as an unscheduled (repeat) assessment.

Länk

https://clinicaltrials.gov/ct2/show/NCT01476046

Nyckelord

Versioner (1)
  1. 2019-09-24 2019-09-24 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

24 september 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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Phase I Trial of Intravenous TNFR1 Antagonist GSK1995057 in Healthy Subjects - NCT01476046

Engelsk

12 Lead ECG

1 Formulär  
  1. StudyEvent: ODM
    1. 12 Lead ECG
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Subject Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Type of Visit
Beskrivning

Identical for all Parts/Cohorts/Subcohorts.

Datatyp

integer

Alias
UMLS CUI [1]
C3641100
Date of Visit
Beskrivning

Date of Visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Dosing Date and Time
Beskrivning

Dosing Date and Time

Alias
UMLS CUI-1
C0178602
UMLS CUI-2
C1264639
Start Dosing date/time
Beskrivning

only applicable to Part A/B Day 1 Visits

Datatyp

datetime

Alias
UMLS CUI [1,1]
C3897500
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0304229
ECG
Beskrivning

ECG

Alias
UMLS CUI-1
C1623258
Time relative to dosing
Beskrivning

On Day 1, record ECGs at the following times (identical for all Parts/Cohorts/Subcohorts). Fill in the entire repeating itemgroup once per ECG.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0304229
Measurement Number
Beskrivning

At Screening, record three ECGs (Measurements 1 to 3). Fill in for repeat ECGs if necessary. Fill in the entire repeating itemgroup once per ECG.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0449788
Date and Time of ECG
Beskrivning

ECG Date / Time

Datatyp

datetime

Alias
UMLS CUI [1]
C2826846
Heart Rate
Beskrivning

Heart Rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Beskrivning

PR Interval

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beskrivning

QRS Duration

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429025
msec
QT Interval
Beskrivning

QT Interval

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1]
C1287082
msec
Method of QTc Calculation: QTcF (Fridericia)?
Beskrivning

i.e. by machine. hidden

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
UMLS CUI [1,3]
C1882513
Method of QTc Calculation: RR interval available?
Beskrivning

i.e. manual hidden

Datatyp

text

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
UMLS CUI [1,3]
C0470187
UMLS CUI [1,4]
C0489636
QTcF Interval
Beskrivning

if applicable

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C1882513
msec
record the RR interval that precedes the measured QT interval:
Beskrivning

if applicable

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0489636
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0855331
msec
Result of the ECG
Beskrivning

if 3 = Abnormal - Clinically significant: complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE

Datatyp

integer

Alias
UMLS CUI [1]
C0438154
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Similar models

12 Lead ECG

1 Formulär
  1. StudyEvent: ODM
    1. 12 Lead ECG
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item
Type of Visit
integer
C3641100 (UMLS CUI [1])
Type of Visit
Code List
Type of Visit
CL Item
Screening (1)
CL Item
Early Withdrawal (2)
CL Item
Part A/B Day 1 (3)
CL Item
Part A/B Day 3 (4)
CL Item
Part A/B Day 5 (5)
CL Item
Part A/B Day 7 (6)
CL Item
Part A/B Day 14 (7)
CL Item
Part A/B Day 28 (8)
CL Item
Repeat Assessment (9)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Dosing Date and Time
C0178602 (UMLS CUI-1)
C1264639 (UMLS CUI-2)
Start Dosing date/time
Item
Start Dosing date/time
datetime
C3897500 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item Group
ECG
C1623258 (UMLS CUI-1)
Item
Time relative to dosing
integer
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Time relative to dosing
Code List
Time relative to dosing
CL Item
Predose 1 (1)
CL Item
Predose 2 (2)
CL Item
Predose 3 (3)
CL Item
2 Hours Post Start of Infusion (4)
CL Item
4 Hours Post Start of Infusion (5)
CL Item
8 Hours Post Start of Infusion (6)
CL Item
12 Hours Post Start of Infusion (7)
ECG Measurement Number
Item
Measurement Number
integer
C0430456 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
ECG Date / Time
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
QT Interval
Item
QT Interval
float
C1287082 (UMLS CUI [1])
Method of QTc Calculation: QTcF (Fridericia)?
Item
Method of QTc Calculation: QTcF (Fridericia)?
boolean
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C1882513 (UMLS CUI [1,3])
Item
Method of QTc Calculation: RR interval available?
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0489636 (UMLS CUI [1,4])
Method of QTC Calculation
Code List
Method of QTc Calculation: RR interval available?
CL Item
RR interval not available (NA)
CL Item
RR interval available (RR)
QTcF Interval
Item
QTcF Interval
float
C0855331 (UMLS CUI [1,1])
C1882513 (UMLS CUI [1,2])
Manual QTc: RR interval
Item
record the RR interval that precedes the measured QT interval:
float
C0489636 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,3])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
ECG Result
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (not available) (4)
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