ID

38181

Description

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 This phase I trial primarily studies the safety and tolerability of ascending single intravenous doses of the selective TNFR1 antagonist GSK1995057 in healthy volunteers, and secondly explores the drug's pharmacodynamics, pharmacokinetics, concentration in lung epithelial lining fluid as well as its effect on immune system markers. The drug is hypothesized to be useful for Acute Lung Injury. 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 the participants' basic vital signs, which are recorded at Screening, on Days 1, 2, 3, 5, 7, 14, 28, in case of early withdrawal and as an unscheduled (repeat) assessment.

Link

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

Keywords

  1. 9/24/19 9/24/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 24, 2019

DOI

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License

Creative Commons BY-NC 3.0

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Phase I Trial of Intravenous TNFR1 Antagonist GSK1995057 in Healthy Subjects - NCT01476046

Vitals Signs

  1. StudyEvent: ODM
    1. Vitals Signs
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Type of Visit
Description

Identical for all Parts/Cohorts/Subcohorts. At Screening, Vital Signs need to be recorded three times. On Day 1, Vital Signs are recorded at the times designated in the "Time relative to dosing" item below.

Data type

integer

Alias
UMLS CUI [1]
C3641100
Date of Visit
Description

Date of Visit

Data type

date

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

Dosing Date and Time

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

only applicable to Part A/B Day 1 Visits

Data type

datetime

Alias
UMLS CUI [1,1]
C3897500
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0304229
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Time relative to dosing
Description

Only applicable on Day 1 (identical for all Parts/Cohorts/Subcohorts). Fill in the entire repeating itemgroup once per Vital Sign assessment on this day.

Data type

integer

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

At Screening, record Vital Signs three times (Measurements 1 to 3). Fill in for repeat Vital Signs if necessary. Fill in the entire repeating itemgroup once per Vital Sign assessment. At Screening, Measurement 1 (of 3), fill in all items. At the two other Screening Measurements, record time, blood pressure, heart rate and respiratory rate.

Data type

integer

Alias
UMLS CUI [1]
C0449788
Actual date/time
Description

Date/time

Data type

datetime

Alias
UMLS CUI [1]
C1264639
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Description

calculated from height and weight

Data type

float

Measurement units
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Blood pressure systolic
Description

Blood pressure systolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure diastolic
Description

Blood pressure diastolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Body Temperature
Description

Body Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Respiration rate
Description

Respiration rate

Data type

integer

Measurement units
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min

Similar models

Vitals Signs

  1. StudyEvent: ODM
    1. Vitals Signs
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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 2 (4)
CL Item
Part A/B Day 3 (5)
CL Item
Part A/B Day 5 (6)
CL Item
Part A/B Day 7 (7)
CL Item
Part A/B Day 14 (8)
CL Item
Part A/B Day 28 (9)
CL Item
Repeat Assessment (10)
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
Vital Signs
C0518766 (UMLS CUI-1)
Item
Time relative to dosing
integer
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Code List
Time relative to dosing
CL Item
Predose (1)
CL Item
2 Hours Post Start of Infusion (2)
CL Item
4 Hours Post Start of Infusion (3)
CL Item
8 Hours Post Start of Infusion (4)
CL Item
12 Hours Post Start of Infusion (5)
Measurement Number
Item
Measurement Number
integer
C0449788 (UMLS CUI [1])
Date/time
Item
Actual date/time
datetime
C1264639 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Blood pressure systolic
Item
Blood pressure systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure diastolic
Item
Blood pressure diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Body Temperature
Item
Body Temperature
float
C0005903 (UMLS CUI [1])
Respiration rate
Item
Respiration rate
integer
C0231832 (UMLS CUI [1])

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