ID

40950

Description

The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitus Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

Keywords

Versions (2)
  1. 4/23/20 4/23/20 -
  2. 6/7/20 6/7/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 7, 2020

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Creative Commons BY-NC 4.0
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A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin

English

ECG Abnormalities - Repeating Form, Logs/Repeats 8-RF-DF

1 forms  
12-LEAD ECG ABNORMALITIES
Description

12-LEAD ECG ABNORMALITIES

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1704258
1. Date and Time of ECG
Description

Date and Time ECG

Data type

datetime

Alias
UMLS CUI [1]
C2826846
2. Record clinically significant abnormalities- A. Rhythm
Description

12 Lead ECG abnormalities Rhythm

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0199556
Other abnormal rhythm, enter comment
Description

other rhythm abnormal

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0199556
UMLS CUI [1,3]
C0205161
UMLS CUI [1,4]
C0947611
2. Record clinically significant abnormalities- B. P-Wave Morphology
Description

12 Lead ECG abnormalities Morphology

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0429072
Other morphology, enter comment
Description

Other morphology

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0332437
UMLS CUI [1,3]
C0430456
UMLS CUI [1,4]
C1704258
UMLS CUI [1,5]
C0947611
2. Record clinically significant abnormalities- C. Conduction
Description

12 Lead ECG abnormalities Cardiac conduction

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0232217
Other conduction, enter comment
Description

Other conduction

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0232217
UMLS CUI [1,3]
C0430456
UMLS CUI [1,4]
C1704258
UMLS CUI [1,5]
C0947611
UMLS CUI [1,6]
C0947611
2. Record clinically significant abnormalities- D. Myocardial Infarction
Description

12 Lead ECG abnormalities Myocardial Infarction

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0027051
Other myocardial infarction, enter comment
Description

Other myocardial infarction

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0027051
UMLS CUI [1,3]
C0947611
2. Record clinically significant abnormalities- E. Depolarisation/Repolarisation (QRS-T)
Description

12 Lead ECG abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [2]
C0948857
Other depolarisation/repolarisation, enter comment
Description

Other repolarisation

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0430456
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C0947611
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C0948857
UMLS CUI [2,3]
C0947611
2. Record clinically significant abnormalities- Other abnormalities, enter comment
Description

E99

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0947611
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Similar models

ECG Abnormalities - Repeating Form, Logs/Repeats 8-RF-DF

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
12-LEAD ECG ABNORMALITIES
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
Date and Time ECG
Item
1. Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
Item
2. Record clinically significant abnormalities- A. Rhythm
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,3])
undefined item
Code List
2. Record clinically significant abnormalities- A. Rhythm
CL Item
Sinus bradycardia  (A1)
C0085610 (UMLS CUI-1)
(Comment:en)
CL Item
Sinus bradycardia (heart rate 40-50 beats/min)  (A21)
C0085610 (UMLS CUI-1)
(Comment:en)
CL Item
Sinus bradycardia (heart rate 30-39 beats/min) (A22)
C0085610 (UMLS CUI-1)
(Comment:en)
CL Item
Sinus bradycardia (heart rate <30 beats/min)  (A23)
C0085610 (UMLS CUI-1)
(Comment:en)
CL Item
Sinus pause  (A3)
C0541782 (UMLS CUI-1)
(Comment:en)
CL Item
Sinus tachycardia (heart rate> 100 beats/min)  (A2)
C0039239 (UMLS CUI-1)
(Comment:en)
CL Item
Ectopic supraventricular beats (A4)
C0033036 (UMLS CUI-1)
(Comment:en)
CL Item
Ectopic supraventricular rhythm (A20)
C2348376 (UMLS CUI-1)
(Comment:en)
CL Item
Wandering atrial pacemaker (A17)
C1321523 (UMLS CUI-1)
(Comment:en)
CL Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate > I 00 beats/min)  (A26)
C0221158 (UMLS CUI-1)
(Comment:en)
CL Item
Supra ventricular tachycardia (heart rate> I 00 beat/min)  (A6)
C0039240 (UMLS CUI-1)
(Comment:en)
CL Item
Atrial flutter (A7)
C0004239 (UMLS CUI-1)
(Comment:en)
CL Item
Atrial fibrillation  (A8)
C0004238 (UMLS CUI-1)
(Comment:en)
CL Item
Junctional rhythm (heart rate<= 100 beat /min)  (A5)
C0232208 (UMLS CUI-1)
(Comment:en)
CL Item
Junctional rhythm  (A25)
C0232208 (UMLS CUI-1)
(Comment:en)
CL Item
Junctional tachycardia (heart rate> I 00 beats/min)  (A24)
C0039235 (UMLS CUI-1)
(Comment:en)
CL Item
Ectopic ventricular beats  (A9)
C0151636 (UMLS CUI-1)
(Comment:en)
CL Item
Ventricular couplets (A12)
C0429001 (UMLS CUI-1)
(Comment:en)
CL Item
Bigeminy  (A13)
C0262662 (UMLS CUI-1)
(Comment:en)
CL Item
Trigeminy  (A28)
C0428999 (UMLS CUI-1)
(Comment:en)
CL Item
Electrical alternans (A14)
C1142551 (UMLS CUI-1)
(Comment:en)
CL Item
R on T phenomenon  (A29)
C0877658 (UMLS CUI-1)
(Comment:en)
CL Item
Ventricular fibrillation  (A18)
C0042510 (UMLS CUI-1)
(Comment:en)
CL Item
ldioventricular rhythm  (A19)
C0700363 (UMLS CUI-1)
(Comment:en)
CL Item
Sustained ventricular tachycardia (A10)
C0750197 (UMLS CUI-1)
(Comment:en)
CL Item
Non-sustained ventricular tachycardia (A11)
C0750194 (UMLS CUI-1)
(Comment:en)
CL Item
Ventricular tachycardia  (A27)
C0042514 (UMLS CUI-1)
(Comment:en)
CL Item
Monomorphic ventricular tachycardia  (A30)
C0344431 (UMLS CUI-1)
(Comment:en)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)  (A15)
C0040479 (UMLS CUI-1)
(Comment:en)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia  (A31)
C0344432 (UMLS CUI-1)
(Comment:en)
CL Item
Artificial Pacemaker (A16)
C0030163 (UMLS CUI-1)
(Comment:en)
CL Item
Other abnormal rhvthm, enter comment (A99)
C0205394 (UMLS CUI-1)
C0199556 (UMLS CUI-2)
C0205161 (UMLS CUI-3)
(Comment:en)
CL Item
Wide QRS tachycardia (diagnosis unknown) (A32)
other rhythm abnormal
Item
Other abnormal rhythm, enter comment
text
C0205394 (UMLS CUI [1,1])
C0199556 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
Item
2. Record clinically significant abnormalities- B. P-Wave Morphology
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0429072 (UMLS CUI [1,3])
undefined item
Code List
2. Record clinically significant abnormalities- B. P-Wave Morphology
CL Item
Left atrial abnormality (P mitrale) (B1)
C0344711 (UMLS CUI-1)
C0232310 (UMLS CUI-2)
(Comment:en)
CL Item
Right atrial abnormality (P pulmonale) (B2)
C0344696 (UMLS CUI-1)
C0232308 (UMLS CUI-2)
(Comment:en)
CL Item
Right ventricular hypertrophy (B3)
C0162770 (UMLS CUI-1)
(Comment:en)
CL Item
Intraatrial conduction delay (B5)
C2346510 (UMLS CUI-1)
(Comment:en)
CL Item
Increased voltage consistent with left ventricular hypertrophy (D14)
C1112650 (UMLS CUI-1)
(Comment:en)
CL Item
other morphology, enter comment (B99)
C0205394 (UMLS CUI-1)
C0522055 (UMLS CUI-2)
C0332437 (UMLS CUI-3)
(Comment:en)
Other morphology
Item
Other morphology, enter comment
text
C0205394 (UMLS CUI [1,1])
C0332437 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,4])
C0947611 (UMLS CUI [1,5])
Item
2. Record clinically significant abnormalities- C. Conduction
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
undefined item
Code List
2. Record clinically significant abnormalities- C. Conduction
CL Item
First degree AV block (PR interval> 200msec) (C1)
C0085614 (UMLS CUI-1)
(Comment:en)
CL Item
Second degree AV block (Mobitz type 1)  (C2)
C0264907 (UMLS CUI-1)
(Comment:en)
CL Item
Second degree AV block (Mobitz type 2)  (C3)
C0155700 (UMLS CUI-1)
(Comment:en)
CL Item
2: 1 AV block  (C16)
C2346542 (UMLS CUI-1)
(Comment:en)
CL Item
Third degree AV block  (C4)
C0151517 (UMLS CUI-1)
(Comment:en)
CL Item
Left axis deviation (QRS axis more negative than -30 degrees)  (C5)
C0232297 (UMLS CUI-1)
(Comment:en)
CL Item
Right axis deviation (QRS axis more positive than+ 110 degrees)  (C6)
C0232296 (UMLS CUI-1)
(Comment:en)
CL Item
Incomplete right bundle branch block  (C7)
C0262525 (UMLS CUI-1)
(Comment:en)
CL Item
Incomplete left bundle branch block  (C13)
C0281878 (UMLS CUI-1)
(Comment:en)
CL Item
Right bundle branch block (C8)
C0085615 (UMLS CUI-1)
(Comment:en)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block)  (C14)
C0264912 (UMLS CUI-1)
(Comment:en)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block)  (C15)
C0264913 (UMLS CUI-1)
(Comment:en)
CL Item
Left bundle branch block (C9)
C0023211 (UMLS CUI-1)
(Comment:en)
CL Item
Bifascicular block  (C17)
C0264914 (UMLS CUI-1)
(Comment:en)
CL Item
Non-specific intraventricular conduction delay (QRS >= 120 msec)  (C10)
C3697597 (UMLS CUI-1)
(Comment:en)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (C11)
C0264897 (UMLS CUI-1)
C0043202 (UMLS CUI-2)
(Comment:en)
CL Item
QT/QTc prolongation >=500msec (C12)
C0855333 (UMLS CUI-1)
(Comment:en)
CL Item
AV dissociation (C18)
C0004331 (UMLS CUI-1)
(Comment:en)
CL Item
Other conduction, enter comment (C99)
C0205394 (UMLS CUI-1)
C0232217 (UMLS CUI-2)
C0522055 (UMLS CUI-3)
(Comment:en)
CL Item
Short PR interval (C20)
CL Item
Prolonged QT interval (C19)
Other conduction
Item
Other conduction, enter comment
text
C0205394 (UMLS CUI [1,1])
C0232217 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,4])
C0947611 (UMLS CUI [1,5])
C0947611 (UMLS CUI [1,6])
Item
2. Record clinically significant abnormalities- D. Myocardial Infarction
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
undefined item
Code List
2. Record clinically significant abnormalities- D. Myocardial Infarction
CL Item
Myocardial infarction, old  (D1)
C0155668 (UMLS CUI-1)
(Comment:en)
CL Item
Myocardial infarction, anterior  (D2)
C0340293 (UMLS CUI-1)
(Comment:en)
CL Item
Myocardial infarction, lateral  (D3)
C0340312 (UMLS CUI-1)
(Comment:en)
CL Item
Myocardial infarction, posterior  (D4)
C0340319 (UMLS CUI-1)
(Comment:en)
CL Item
Myocardial infarction, inferior  (D5)
C0340305 (UMLS CUI-1)
(Comment:en)
CL Item
Myocardial infarction, septal  (D6)
C0746727 (UMLS CUI-1)
(Comment:en)
CL Item
Myocardial infarction, Non Q-wave  (D20)
C0542269 (UMLS CUI-1)
(Comment:en)
CL Item
Other myocardial infarction, enter comment (D98)
C0205394 (UMLS CUI-1)
C0027051 (UMLS CUI-2)
(Comment:en)
Other myocardial infarction
Item
Other myocardial infarction, enter comment
text
C0205394 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item
2. Record clinically significant abnormalities- E. Depolarisation/Repolarisation (QRS-T)
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0948857 (UMLS CUI [2])
undefined item
Code List
2. Record clinically significant abnormalities- E. Depolarisation/Repolarisation (QRS-T)
CL Item
Non-specific ST-T changes  (D7)
C1112720 (UMLS CUI-1)
(Comment:en)
CL Item
J point elevation  (D19)
C2346597 (UMLS CUI-1)
(Comment:en)
CL Item
ST elevation  (D8)
C0520886 (UMLS CUI-1)
(Comment:en)
CL Item
ST-elevation - pericarditis  (D21)
C2348119 (UMLS CUI-1)
(Comment:en)
CL Item
ST depression  (D9)
C0520887 (UMLS CUI-1)
(Comment:en)
CL Item
U waves abnormal (D10)
C0438169 (UMLS CUI-1)
(Comment:en)
CL Item
T wave inversion  (D11)
C0520888 (UMLS CUI-1)
(Comment:en)
CL Item
T wave peaked  (D12)
C0239242 (UMLS CUI-1)
(Comment:en)
CL Item
T waves flat  (D15)
C2215959 (UMLS CUI-1)
(Comment:en)
CL Item
T waves biphasic  (D16)
C2348639 (UMLS CUI-1)
(Comment:en)
CL Item
Notched T-waves  (D18)
C2347367 (UMLS CUI-1)
(Comment:en)
CL Item
Low QRS voltage  (D13)
C2349945 (UMLS CUI-1)
(Comment:en)
CL Item
T-wave flattening/inversion  (D17)
C0520888 (UMLS CUI-1)
C0429059 (UMLS CUI-2)
(Comment:en)
CL Item
Other depolarisation/repolarisation, enter comment (D99)
C0205394 (UMLS CUI-1)
C0948857 (UMLS CUI-2)
(Comment:en)
Other repolarisation
Item
Other depolarisation/repolarisation, enter comment
text
C0205394 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0205394 (UMLS CUI [2,1])
C0948857 (UMLS CUI [2,2])
C0947611 (UMLS CUI [2,3])
other 12 Lead ECG abnormalities
Item
2. Record clinically significant abnormalities- Other abnormalities, enter comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
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