ID
38180
Descripción
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.
Link
https://clinicaltrials.gov/ct2/show/NCT01476046
Palabras clave
Versiones (1)
- 24/9/19 24/9/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
24 de septiembre de 2019
DOI
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Licencia
Creative Commons BY-NC 3.0
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Phase I Trial of Intravenous TNFR1 Antagonist GSK1995057 in Healthy Subjects - NCT01476046
12 Lead ECG
- StudyEvent: ODM
Descripción
Dosing Date and Time
Alias
- UMLS CUI-1
- C0178602
- UMLS CUI-2
- C1264639
Descripción
ECG
Alias
- UMLS CUI-1
- C1623258
Descripción
On Day 1, record ECGs at the following times (identical for all Parts/Cohorts/Subcohorts). Fill in the entire repeating itemgroup once per ECG.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C3469597
- UMLS CUI [1,3]
- C0304229
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0449788
Descripción
ECG Date / Time
Tipo de datos
datetime
Alias
- UMLS CUI [1]
- C2826846
Descripción
Heart Rate
Tipo de datos
integer
Unidades de medida
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Descripción
PR Interval
Tipo de datos
float
Unidades de medida
- msec
Alias
- UMLS CUI [1]
- C0429087
Descripción
QRS Duration
Tipo de datos
float
Unidades de medida
- msec
Alias
- UMLS CUI [1]
- C0429025
Descripción
QT Interval
Tipo de datos
float
Unidades de medida
- msec
Alias
- UMLS CUI [1]
- C1287082
Descripción
i.e. by machine. hidden
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
- UMLS CUI [1,3]
- C1882513
Descripción
i.e. manual hidden
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
- UMLS CUI [1,3]
- C0470187
- UMLS CUI [1,4]
- C0489636
Descripción
if applicable
Tipo de datos
float
Unidades de medida
- msec
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C1882513
Descripción
if applicable
Tipo de datos
float
Unidades de medida
- msec
Alias
- UMLS CUI [1,1]
- C0489636
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0855331
Descripción
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
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0438154
Similar models
12 Lead ECG
- StudyEvent: ODM
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
C1882513 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0489636 (UMLS CUI [1,4])
C1882513 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,3])