Informações:
Falhas:
ID
41711
Descrição
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive
Palavras-chave
Versões (1)
- 02/01/2021 02/01/2021 -
Titular dos direitos
GlaxoSmithKline
Transferido a
2 de janeiro de 2021
DOI
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Licença
Creative Commons BY 4.0
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Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673
Part 2, Period 4, Cohort 1 Day 1: Local Laboratory; Investigational Product; ECG; Vital Signs; Pulmonary Function Tests; Holter Summary; Holter Abnormalities
Similar models
Part 2, Period 4, Cohort 1 Day 1: Local Laboratory; Investigational Product; ECG; Vital Signs; Pulmonary Function Tests; Holter Summary; Holter Abnormalities
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Local Laboratory - Haematology (Part 2 Period 4)
Date and time sample taken (Haematology)
Item
Date and time sample taken (Haematology)
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0018941 (UMLS CUI [2])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0018941 (UMLS CUI [2])
Has the subject fasted? (Haematology)
Item
Has the subject fasted? (Haematology)
boolean
C0015663 (UMLS CUI [1])
C0018941 (UMLS CUI [2])
C0018941 (UMLS CUI [2])
Item Group
Local Laboratory - Haematology (Part 2 Period 4)
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
C0474523 (UMLS CUI-2)
CL Item
WBC (1)
CL Item
RBC (2)
CL Item
Hameoglobin (3)
CL Item
Haematocrit (4)
CL Item
Neutrophils (5)
CL Item
Lymphocytes (6)
CL Item
Monocytes (7)
CL Item
Eosinophils (8)
CL Item
Basophils (9)
CL Item
MCV (10)
CL Item
MCH (11)
CL Item
MCHC (12)
Numeric result (Haemoatology)
Item
Numeric result (Haemoatology)
float
C2347373 (UMLS CUI [1])
C0474523 (UMLS CUI [2])
C0474523 (UMLS CUI [2])
Character result (Haematology)
Item
Character result (Haematology)
text
C2350015 (UMLS CUI [1])
C0474523 (UMLS CUI [2])
C0474523 (UMLS CUI [2])
CL Item
No result (1)
Item Group
Local Laboratory - Clinical Chemistry (Part 2 Period 4)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C0008000 (UMLS CUI-2)
Date and time sample taken (Clinical Chemistry)
Item
Date and time sample taken (Clinical Chemistry)
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0008000 (UMLS CUI [2])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0008000 (UMLS CUI [2])
Has the subject fasted? (Clinical Chemistry)
Item
Has the subject fasted? (Clinical Chemistry)
boolean
C0015663 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
C0008000 (UMLS CUI [2])
Item Group
Local Laboratory - Clinical Chemistry (Part 2 Period 4)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C0008000 (UMLS CUI-2)
CL Item
ALT (1)
CL Item
AST (2)
CL Item
Total Bilrubin (3)
CL Item
Direct Bilirubin (4)
CL Item
Glucose Fasting (5)
CL Item
GGT (6)
CL Item
Total Protein (7)
CL Item
Albumin (8)
CL Item
Potassium (9)
CL Item
Sodium (10)
CL Item
Calcium (11)
CL Item
Urea (12)
CL Item
Creatinine (13)
CL Item
Uric Acid (14)
CL Item
Alkaline Phosphatase (15)
Numeric result (Clinical Chemistry)
Item
Numeric result (Clinical Chemistry)
float
C2347373 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
C0008000 (UMLS CUI [2])
Character result (Clinical Chemistry)
Item
Character result (Clinical Chemistry)
text
C2350015 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
C0008000 (UMLS CUI [2])
Item
No result (Clinical Chemistry)
integer
C0587081 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
C0008000 (UMLS CUI [2])
CL Item
No result (1)
Item Group
Investigational Product (Dose) (Part 2 Period 4)
C0304229 (UMLS CUI-1)
Date/time of dose
Item
Date/time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Number of Inhalations
Item
Number of Inhalations
integer
C0354922 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
Item
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
If subject did not recieve the correct treatment, record reason
Item
If subject did not recieve the correct treatment, record reason
text
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2])
C2349182 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2])
Dosing date/time (ECG)
Item
Dosing date/time (ECG)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1623258 (UMLS CUI [2])
C1264639 (UMLS CUI [1,2])
C1623258 (UMLS CUI [2])
CL Item
Pre-Dose 1 (1)
CL Item
Pre-Dose 2 (2)
CL Item
Pre-Dose 3 (3)
CL Item
15 mins Post-Dose (4)
CL Item
45 mins Post-Dose (5)
CL Item
90 mins Post-Dose (6)
CL Item
4 hours Post-Dose (7)
CL Item
8 hours Post-Dose (8)
CL Item
12 hours Post-Dose (9)
Time of ECG
Item
Time of ECG
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0489625 (UMLS CUI [1])
QTc (b) Interval
Item
QTc (b) Interval
integer
C1882512 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
CL Item
Machine (1)
CL Item
Manual (2)
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
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) (3)
CL Item
No result (not available) (4)
Dosing date/time (Vital Signs)
Item
Dosing date/time (Vital Signs)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0518766 (UMLS CUI [2])
C1264639 (UMLS CUI [1,2])
C0518766 (UMLS CUI [2])
Item
Vital Signs Timepoint
integer
C0518766 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,2])
CL Item
Pre-Dose 1 (1)
CL Item
Pre-Dose 2 (2)
CL Item
Pre-Dose 3 (3)
CL Item
15 mins Post-Dose (4)
CL Item
45 mins Post-Dose (5)
CL Item
90 mins Post-Dose (6)
CL Item
4 hours Post-Dose (7)
CL Item
8 hours Post-Dose (8)
CL Item
12 hours Post-Dose (9)
Actual time
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Local Laboratory - Haematology (24Hr Lab) (Part 2 Period 4)
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
C0474523 (UMLS CUI-2)
Date and time sample taken (Haematology, 24 Hr Lab)
Item
Date and time sample taken (Haematology, 24 Hr Lab)
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0018941 (UMLS CUI [2])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0018941 (UMLS CUI [2])
Has the subject fasted? (Haematology, 24 Hr Lab)
Item
Has the subject fasted? (Haematology, 24 Hr Lab)
boolean
C0015663 (UMLS CUI [1])
C0018941 (UMLS CUI [2])
C0018941 (UMLS CUI [2])
Item Group
Local Laboratory - Haematology (24 Hr Lab) (Part 2 Period 4)
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
C0474523 (UMLS CUI-2)
CL Item
WBC (1)
CL Item
RBC (2)
CL Item
Hameoglobin (3)
CL Item
Haematocrit (4)
CL Item
Neutrophils (5)
CL Item
Lymphocytes (6)
CL Item
Monocytes (7)
CL Item
Eosinophils (8)
CL Item
Basophils (9)
CL Item
MCV (10)
CL Item
MCH (11)
CL Item
MCHC (12)
Numeric result (Haemoatology, 24 Hr Lab)
Item
Numeric result (Haemoatology, 24 Hr Lab)
float
C2347373 (UMLS CUI [1])
C0474523 (UMLS CUI [2])
C0474523 (UMLS CUI [2])
Character result (Haematology, 24 Hr Lab)
Item
Character result (Haematology, 24 Hr Lab)
text
C2350015 (UMLS CUI [1])
C0474523 (UMLS CUI [2])
C0474523 (UMLS CUI [2])
Item
No result (Haematology, 24 Hr Lab)
integer
C0474523 (UMLS CUI [1])
CL Item
No result (1)
Item Group
Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C0008000 (UMLS CUI-2)
Date and time sample taken (Clinical Chemistry, 24 Hr Lab)
Item
Date and time sample taken (Clinical Chemistry, 24 Hr Lab)
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0008000 (UMLS CUI [2])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0008000 (UMLS CUI [2])
Has the subject fasted? (Clinical Chemistry, 24 Hr Lab)
Item
Has the subject fasted? (Clinical Chemistry, 24 Hr Lab)
boolean
C0015663 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
C0008000 (UMLS CUI [2])
Item Group
Local Laboratory - Clinical Chemistry (24 Hr Lab) (Part 2 Period 4)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C0008000 (UMLS CUI-2)
Item
Clinical Chemistry Test (24 Hr Lab)
integer
C0525044 (UMLS CUI [1])
CL Item
ALT (1)
CL Item
AST (2)
CL Item
Total Bilrubin (3)
CL Item
Direct Bilirubin (4)
CL Item
Glucose Fasting (5)
CL Item
GGT (6)
CL Item
Total Protein (7)
CL Item
Albumin (8)
CL Item
Potassium (9)
CL Item
Sodium (10)
CL Item
Calcium (11)
CL Item
Urea (12)
CL Item
Creatinine (13)
CL Item
Uric Acid (14)
CL Item
Alkaline Phosphatase (15)
Numeric result (Clinical Chemistry, 24 Hr Lab)
Item
Numeric result (Clinical Chemistry, 24 Hr Lab)
float
C2347373 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
C0008000 (UMLS CUI [2])
Character result (Clinical Chemistry, 24 Hr Lab)
Item
Character result (Clinical Chemistry, 24 Hr Lab)
text
C2350015 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
C0008000 (UMLS CUI [2])
Item
No result (Clinical Chemistry, 24 Hr Lab)
integer
C0587081 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
C0008000 (UMLS CUI [2])
CL Item
No result (1)
Item Group
Pulmonary Function Tests (Part 2 Period 4)
C0024119 (UMLS CUI-1)
Dosing date/time (Pulmonary Function Tests)
Item
Dosing date/time (Pulmonary Function Tests)
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0024119 (UMLS CUI [2])
C1264639 (UMLS CUI [1,2])
C0024119 (UMLS CUI [2])
Item Group
Pulmonary Function Tests (Part 2 Period 4)
C0024119 (UMLS CUI-1)
Item
Pulmonary Function Tests Timepoint
integer
C0024119 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,2])
CL Item
Pre-Dose (1)
CL Item
30 mins Post-Dose (2)
CL Item
2 hours Post-Dose (3)
Date/time of test
Item
Date/time of test
datetime
C0024119 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
FEV (3 readings) - 1
Item
FEV (3 readings) - 1
integer
C0748133 (UMLS CUI [1])
FEV (3 readings) - 2
Item
FEV (3 readings) - 2
integer
C0748133 (UMLS CUI [1])
FEV (3 readings) - 3
Item
FEV (3 readings) - 3
integer
C0748133 (UMLS CUI [1])
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