ID

38498

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 is to be filled in at the end of the study (regular follow-up or study discontinuation) and lists whether any repeated/additional investigations were performed and/or whether certain events occured in the participant, such as (Non-)Serious Adverse Events. Details about the investigations/events are recorded in different forms.

Link

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

Keywords

  1. 10/22/19 10/22/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 22, 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

Logs and Repeats

  1. StudyEvent: ODM
    1. Logs and Repeats
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Date/time of visit/assessment
Description

Date is the start of the study for this subject

Data type

datetime

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C0545082
UMLS CUI [2,1]
C1264639
UMLS CUI [2,2]
C1516048
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Adverse Event/Concomitant Medication/Unscheduled Assessment Check Questions
Description

Adverse Event/Concomitant Medication/Unscheduled Assessment Check Questions

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2347852
UMLS CUI-3
C3854240
UMLS CUI-4
C0220825
Were any concomitant medications taken by the subject during the study?
Description

Concomitant medication

Data type

text

Alias
UMLS CUI [1]
C2347852
Did the subject experience any non-serious adverse events during the study?
Description

Non-serious adverse events

Data type

text

Alias
UMLS CUI [1]
C1518404
Did the subject experience any serious adverse events during the study?
Description

Serious adverse events

Data type

text

Alias
UMLS CUI [1]
C1519255
Were any unscheduled ECGs performed?
Description

Unscheduled ECGs

Data type

text

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C3854240
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
Description

Abnormal, clinically significant ECG

Data type

text

Alias
UMLS CUI [1,1]
C1832603
UMLS CUI [1,2]
C2985739
Were any unscheduled vital signs recorded?
Description

Unscheduled vital signs

Data type

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C3854240
Were any unscheduled Spirometry tests performed?
Description

Unscheduled spirometry

Data type

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C0037981
Were any unscheduled PK blood samples taken?
Description

Unscheduled pharmacokinetic samples

Data type

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0005834
Were any unscheduled Holter performed?
Description

Unscheduled Holter

Data type

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C3854240
Were any abnormal, clinically significant Holter or Telemetry measurements recorded for this subject during the study?
Description

Abnormal, clinically significant Holter or Telemetry

Data type

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0522055
UMLS CUI [1,3]
C2826293
UMLS CUI [2,1]
C0039451
UMLS CUI [2,2]
C2826293
UMLS CUI [2,3]
C0205161
Was a unscheduled Immunogenicity performed?
Description

Unscheduled Immunogenicity

Data type

text

Alias
UMLS CUI [1,1]
C4054739
UMLS CUI [1,2]
C3854240
Was a unscheduled Biomarker Serum performed?
Description

Unscheduled Biomarker Serum

Data type

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C0005516
UMLS CUI [1,3]
C0229671
Was a unscheduled Biomarker WBA performed?
Description

Unscheduled Biomarker Assessment from Whole Blood

Data type

text

Alias
UMLS CUI [1,1]
C3854240
UMLS CUI [1,2]
C0005516
UMLS CUI [1,3]
C0370231
Did GSK Monitor identify any protocol deviations for this subject?
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C1705236
Liver Event
Description

Liver Event

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Description

If yes, please complete the Liver Event form(s).

Data type

text

Alias
UMLS CUI [1,1]
C0023901
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0587081
UMLS CUI [1,4]
C0243161
UMLS CUI [1,5]
C2746065
UMLS CUI [1,6]
C0304229

Similar models

Logs and Repeats

  1. StudyEvent: ODM
    1. Logs and Repeats
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date/time of visit/assessment
Item
Date/time of visit/assessment
datetime
C1264639 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Adverse Event/Concomitant Medication/Unscheduled Assessment Check Questions
C0877248 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C3854240 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
Item
Were any concomitant medications taken by the subject during the study?
text
C2347852 (UMLS CUI [1])
Code List
Were any concomitant medications taken by the subject during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Did the subject experience any non-serious adverse events during the study?
text
C1518404 (UMLS CUI [1])
Code List
Did the subject experience any non-serious adverse events during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Did the subject experience any serious adverse events during the study?
text
C1519255 (UMLS CUI [1])
Code List
Did the subject experience any serious adverse events during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any unscheduled ECGs performed?
text
C0013798 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
Code List
Were any unscheduled ECGs performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
text
C1832603 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Code List
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any unscheduled vital signs recorded?
text
C0518766 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
Code List
Were any unscheduled vital signs recorded?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any unscheduled Spirometry tests performed?
text
C3854240 (UMLS CUI [1,1])
C0037981 (UMLS CUI [1,2])
Code List
Were any unscheduled Spirometry tests performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any unscheduled PK blood samples taken?
text
C3854240 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])
Code List
Were any unscheduled PK blood samples taken?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any unscheduled Holter performed?
text
C0013801 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
Code List
Were any unscheduled Holter performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any abnormal, clinically significant Holter or Telemetry measurements recorded for this subject during the study?
text
C0013801 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0039451 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0205161 (UMLS CUI [2,3])
Code List
Were any abnormal, clinically significant Holter or Telemetry measurements recorded for this subject during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was a unscheduled Immunogenicity performed?
text
C4054739 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
Code List
Was a unscheduled Immunogenicity performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was a unscheduled Biomarker Serum performed?
text
C3854240 (UMLS CUI [1,1])
C0005516 (UMLS CUI [1,2])
C0229671 (UMLS CUI [1,3])
Code List
Was a unscheduled Biomarker Serum performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was a unscheduled Biomarker WBA performed?
text
C3854240 (UMLS CUI [1,1])
C0005516 (UMLS CUI [1,2])
C0370231 (UMLS CUI [1,3])
Code List
Was a unscheduled Biomarker WBA performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Did GSK Monitor identify any protocol deviations for this subject?
text
C1705236 (UMLS CUI [1])
Code List
Did GSK Monitor identify any protocol deviations for this subject?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Liver Event
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
text
C0023901 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C2746065 (UMLS CUI [1,5])
C0304229 (UMLS CUI [1,6])
Code List
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
CL Item
Yes (Y)
CL Item
No (N)

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