ID

38587

Beschrijving

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 continously during the study and/or at the follow-up evaluation and contains information on other medication the participant has received during the course of the study.

Link

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

Trefwoorden

Versies (1)
  1. 25-10-19 25-10-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

25 oktober 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

  • Nieuwste
  • Oudste
  • Populair
  • Nieuwste
    • Nieuwste
    • Oudste
    • Populair

Geen commentaren

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

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

Engels

Concomitant Medications

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722 (Administrative documentation)
SNOMED
405624007
Subject Number
Beschrijving

Subject Number

Datatype

integer

Alias
UMLS CUI [1]
C2348585 (Clinical Trial Subject Unique Identifier)
Date/Time of Assessment
Beschrijving

Date/Time of Assessment

Datatype

datetime

Alias
UMLS CUI [1,1]
C2985720 (Assessment Date)
UMLS CUI [1,2]
C1264639 (Date/Time)
SNOMED
118575009
Concomitant Medications
Beschrijving

Concomitant Medications

Alias
UMLS CUI-1
C2347852 (Concomitant Agent)
Concomitant Medication Number
Beschrijving

Concomitant Medication Number

Datatype

integer

Alias
UMLS CUI [1,1]
C2347852 (Concomitant Agent)
UMLS CUI [1,2]
C0600091 (Identifier)
SNOMED
118522005
LOINC
LP31795-5
Sequence Number
Beschrijving

Sequence Number

Datatype

text

Alias
UMLS CUI [1]
C2348184 (Sequence Number)
Drug name
Beschrijving

Trade Name preferred

Datatype

text

Alias
UMLS CUI [1]
C2360065 (Medication name)
LOINC
MTHU027854
Concomitant Medication Modified Reported Term
Beschrijving

[hidden]

Datatype

text

Alias
UMLS CUI [1]
C2826819 (Concomitant Medication Modified Reported Term)
GSK Drug synonym
Beschrijving

[hidden]

Datatype

text

Alias
UMLS CUI [1,1]
C0013227 (Pharmaceutical Preparations)
SNOMED
763158003
LOINC
LP100609-9
UMLS CUI [1,2]
C0871468 (Synonym)
GSK Drug Collection code
Beschrijving

[hidden]

Datatype

text

Alias
UMLS CUI [1,1]
C0013227 (Pharmaceutical Preparations)
SNOMED
763158003
LOINC
LP100609-9
UMLS CUI [1,2]
C1516698 (Collection (action))
LOINC
LP20988-9
UMLS CUI [1,3]
C0805701 (Code)
Failed coding
Beschrijving

[hidden]

Datatype

boolean

Alias
UMLS CUI [1,1]
C0805701 (Code)
UMLS CUI [1,2]
C0231175 (Failed)
Unit Dose
Beschrijving

Concomitant Medication Unit Dose

Datatype

text

Alias
UMLS CUI [1]
C2826811 (Concomitant Medication Dose)
Units of concomitant medication
Beschrijving

Concomitant Medication Units

Datatype

text

Alias
UMLS CUI [1]
C2826646 (Concomitant Medication Dose Unit)
Frequency
Beschrijving

Concomitant Medication Frequency

Datatype

text

Alias
UMLS CUI [1]
C2826654 (Concomitant Medication Dose Frequency)
Route
Beschrijving

Concomitant Medication Route

Datatype

text

Alias
UMLS CUI [1]
C2826730 (Concomitant Medication Route of Administration)
Reason for Medication
Beschrijving

Concomitant Medication reason

Datatype

text

Alias
UMLS CUI [1]
C2826696 (Concomitant Medication Use Indication)
Start Date and Time
Beschrijving

Concomitant Medication start date/time

Datatype

partialDatetime

Alias
UMLS CUI [1]
C2826825 (Concomitant Medication Use Start Date Time)
Concomitant Medication Taken Prior to Study?
Beschrijving

Concomitant Medication Taken Prior to Study?

Datatype

text

Alias
UMLS CUI [1]
C2826667 (Concomitant Medication Previous Occurrence)
Ongoing?
Beschrijving

If no, specify End Date and Time

Datatype

text

Alias
UMLS CUI [1]
C2826666 (Concomitant Medication Ongoing)
If no, specify End Date and Time
Beschrijving

Concomitant Medication end date/time

Datatype

partialDatetime

Alias
UMLS CUI [1]
C2826815 (Concomitant Medication Use End Date Time)
Terug naar het begin van de pagina

Similar models

Concomitant Medications

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date/Time of Assessment
Item
Date/Time of Assessment
datetime
C2985720 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Concomitant Medication Number
Item
Concomitant Medication Number
integer
C2347852 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1])
Drug name
Item
Drug name
text
C2360065 (UMLS CUI [1])
Concomitant Medication Modified Reported Term
Item
Concomitant Medication Modified Reported Term
text
C2826819 (UMLS CUI [1])
Drug synonym
Item
GSK Drug synonym
text
C0013227 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
Drug Collection code
Item
GSK Drug Collection code
text
C0013227 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Failed coding
Item
Failed coding
boolean
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Concomitant Medication Unit Dose
Item
Unit Dose
text
C2826811 (UMLS CUI [1])
Item
Units of concomitant medication
text
C2826646 (UMLS CUI [1])
Units
Code List
Units of concomitant medication
CL Item
Actuation (ACTU)
CL Item
Ampoule (AMP)
CL Item
Application (APP)
CL Item
Area under curve (AUC)
CL Item
Bottle (BOT)
CL Item
Capsule (CAP)
CL Item
Cubic centimeter (CC)
CL Item
Cup (CUP)
CL Item
Gamma per kilogram per minute (GA/KG/MIN)
CL Item
Gram (G)
CL Item
Drops (GTT)
CL Item
100 International units/ml (100IU/ML)
CL Item
Inhalation (INH)
CL Item
International Units (IU)
CL Item
International units per kilogram (IU/KG)
CL Item
International units per kilogram per hour (IU/KG/HR)
CL Item
International units per millilitre (IU/ML)
CL Item
Litre (L)
CL Item
Lozenge (LOZ)
CL Item
Litre per minute (L/MIN)
CL Item
Minimum alveolar concentration (MAC)
CL Item
Mega becquerels (MBq) (MBQ)
CL Item
Microgram (MCG) (MCG)
CL Item
Micrograms per hour (MCG/HR)
CL Item
Microgram/kilogram (MCG/KG)
CL Item
Microgram/kilogram per minute (MCG/KG/MIN)
CL Item
Micrograms per minute (MCG/MIN)
CL Item
Micrograms per millitre (MCG/ML)
CL Item
Microlitre (MCL)
CL Item
Milliequivalent (MEQ)
CL Item
Milliequivalents per 24 hours (MEQ/24HR)
CL Item
Milligram (MG)
CL Item
Milligram per day (MG/DAY)
CL Item
Milligram per hour (MG/HR)
CL Item
Milligram per kilogram (MG/KG)
CL Item
Milligram per kilogram per hour (MG/KG/HR)
CL Item
Milligram per kilogram per minute (MG/KG/MIN)
CL Item
Milligrams per metre squared (MG/M2)
CL Item
Milligrams per millilitre (MG/ML)
CL Item
Milligrams percent (MG%)
CL Item
Million international units (MIU)
CL Item
Millilitre (ML)
CL Item
Millilitres per hour (ML/HR)
CL Item
Millilitres per minute (ML/MIN)
CL Item
Millimole (MMOL)
CL Item
Megaunits (million units) (MU)
CL Item
Nebule (NEB)
CL Item
Ounce (OZ)
CL Item
Patch (PATCH)
CL Item
Percent (%)
CL Item
Puff (PUFF)
CL Item
Sachet (SACH)
CL Item
Spray (SPR)
CL Item
Suppository (SUPP)
CL Item
Tablet (TAB)
CL Item
Tablespoon (TBLSP)
CL Item
Teaspoon (TSP)
CL Item
Microgram (UG) (UG)
CL Item
Units per hour (U/HR)
CL Item
Units per kilogram per minute (U/KG/MIN)
CL Item
Units per minute (U/MIN)
CL Item
Units (U)
CL Item
Unknown (UNK)
CL Item
Vial (VIAL)
Item
Frequency
text
C2826654 (UMLS CUI [1])
Frequency
Code List
Frequency
CL Item
3 times per week (2XWK)
CL Item
3 times per week (3XWK)
CL Item
4 times per week (4XWK)
CL Item
5 times per day (5XD)
CL Item
5 times per week (5XWK)
CL Item
AC (AC)
CL Item
BID (BID)
CL Item
Continuous infusion (CINF)
CL Item
HS (HS)
CL Item
Once daily (OD)
CL Item
Once only (ONE)
CL Item
PC (PC)
CL Item
PRN (PRN)
CL Item
Q12H (Q12H)
CL Item
Q2H (Q2H)
CL Item
every 2 weeks (Q2WK)
CL Item
Q3D (Q3D)
CL Item
Every 3 weeks (Q3WK)
CL Item
Every 3 months (Q3M)
CL Item
Q4D (Q4D)
CL Item
Q4H (Q4H)
CL Item
Q6H (Q6H)
CL Item
Q8H (Q8H)
CL Item
QAM (QAM)
CL Item
QH (QH)
CL Item
QID (QID)
CL Item
once a month (QM)
CL Item
every other day (QOD)
CL Item
QPM (QPM)
CL Item
once a week (QWK)
CL Item
TID (TID)
CL Item
Unknown (UNK)
Item
Route
text
C2826730 (UMLS CUI [1])
Route
Code List
Route
CL Item
Epidural (EP)
CL Item
Gastrostomy tube (GTT)
CL Item
Intra-arterial (IA)
CL Item
Intra-bursa (IB)
CL Item
intradermal (ID)
CL Item
Inhalation (IH)
CL Item
intralesional (ILES)
CL Item
Intramuscular (IM)
CL Item
Intranasal (IN)
CL Item
Injection (INJ)
CL Item
Inraocular (IO)
CL Item
Intraosteal (IOS)
CL Item
intraperitoneal (IP)
CL Item
Intrathecal (IT)
CL Item
Intrauterine (IU)
CL Item
Intravenous (IV)
CL Item
Jejunostomy feeding tube (JEJ or PEJ) (JEJ)
CL Item
nasogastric (NG)
CL Item
Nasal (NS)
CL Item
right eye (OD)
CL Item
opthalmic (OP)
CL Item
left eye (OS)
CL Item
other (OTH)
CL Item
both eyes (OU)
CL Item
Oral (PO)
CL Item
Rectal (PR)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Transmucosal (TM)
CL Item
Topical (TP)
CL Item
Unknown (UNK)
CL Item
Vaginal (VG)
Concomitant Medication reason
Item
Reason for Medication
text
C2826696 (UMLS CUI [1])
Concomitant Medication start date/time
Item
Start Date and Time
partialDatetime
C2826825 (UMLS CUI [1])
Item
Concomitant Medication Taken Prior to Study?
text
C2826667 (UMLS CUI [1])
Concomitant Medication Taken Prior to Study?
Code List
Concomitant Medication Taken Prior to Study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Ongoing?
text
C2826666 (UMLS CUI [1])
Concomitant Medication Taken Prior to Study?
Code List
Ongoing?
CL Item
Yes (Y)
CL Item
No (N)
Concomitant Medication end date/time
Item
If no, specify End Date and Time
partialDatetime
C2826815 (UMLS CUI [1])
Terug naar het begin van de pagina 

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial