ID

40953

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. 4/25/20 4/25/20 -
  2. 6/7/20 6/7/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 7, 2020

DOI

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License

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

Medical conditions (Liver MEDHX), Liver Event 5-DF

1 forms  
Liver disease medical conditions
Description

Liver disease medical conditions

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0262926
1. Acute Viral Hepatitis A
Description

Acute Viral Hepatitis A

Data type

integer

Alias
UMLS CUI [1]
C0276434
2. Chronic Hepatitis B
Description

Chronic Hepatitis B

Data type

integer

Alias
UMLS CUI [1]
C0524909
3. Chronic Hepatitis C
Description

Chronic Hepatitis C

Data type

integer

Alias
UMLS CUI [1]
C0524910
4. Cytomegalovirus Hepatitis
Description

Cytomegalovirus Hepatitis

Data type

integer

Alias
UMLS CUI [1]
C0276252
5. Epstein Barr Virus Infectious Mononucleosis
Description

Epstein Barr Virus Infectious Mononucleosis

Data type

integer

Alias
UMLS CUI [1,1]
C0021345
UMLS CUI [1,2]
C0014644
6. Herpes Simplex Hepatitis
Description

Herpes Simplex Hepatitis

Data type

integer

Alias
UMLS CUI [1]
C1963747
7. Alcoholic Liver Disease
Description

Alcoholic Liver Disease

Data type

integer

Alias
UMLS CUI [1]
C0023896
8. Non-alcoholic Steatohepatitis
Description

Non-alcoholic Steatohepatitis

Data type

integer

Alias
UMLS CUI [1]
C3241937
9. Fatty Liver
Description

Fatty Liver

Data type

integer

Alias
UMLS CUI [1]
C0015695
10. Hepatic Cirrhosis
Description

Hepatic Cirrhosis

Data type

integer

Alias
UMLS CUI [1]
C0023890
11. Hemochromatosis
Description

Hemochromatosis

Data type

integer

Alias
UMLS CUI [1]
C0018995
12. Autoimmune Hepatitis
Description

Autoimmune Hepatitis

Data type

integer

Alias
UMLS CUI [1]
C0241910
13. Gallbladder disease or biliary disease
Description

Gallbladder disease or biliary disease

Data type

integer

Alias
UMLS CUI [1]
C0016977
UMLS CUI [2]
C3275124
Drug related liver disease conditions (All drugs including Investigational Product)
Description

Drug related liver disease conditions (All drugs including Investigational Product)

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0277579
14. Drug related liver disease
Description

Drug related liver disease

Data type

integer

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0277579
Other liver disease conditions
Description

Other liver disease conditions

15.a Sequence Number
Description

[hidden] Item is not required

Data type

text

Alias
UMLS CUI [1]
C2348184
15. Specific Condition
Description

Specific Condition

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
15.c Modified Term
Description

[hidden] Item is not required

Data type

text

Alias
UMLS CUI [1]
C2826302
MedDRA Synonym
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C1140263
MedDRA lower level term code
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C2347090
Failed coding
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
15.d Status
Description

Status

Data type

integer

Alias
UMLS CUI [1]
C0449438
Other medical conditions
Description

Other medical conditions

16. Drug Allergies
Description

Drug Allergies

Data type

integer

Alias
UMLS CUI [1]
C0013182
17. Rheumatoid Arthritis
Description

Rheumatoid Arthritis

Data type

integer

Alias
UMLS CUI [1]
C0003873
18. Psoriasis
Description

Psoriasis

Data type

integer

Alias
UMLS CUI [1]
C0033860
19. Thyroid Disease
Description

Thyroid Disease

Data type

integer

Alias
UMLS CUI [1]
C0040128
20. Inflammatory Bowel Disease
Description

Inflammatory Bowel Disease

Data type

integer

Alias
UMLS CUI [1]
C0021390
21. Lupus
Description

Lupus

Data type

integer

Alias
UMLS CUI [1]
C0409974
22. Sjogren's Syndrome
Description

Sjogren's Syndrome

Data type

integer

Alias
UMLS CUI [1]
C1527336
23. Vitiligo
Description

Vitiligo

Data type

integer

Alias
UMLS CUI [1]
C0042900
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Similar models

Medical conditions (Liver MEDHX), Liver Event 5-DF

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Liver disease medical conditions
C0023895 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Item
1. Acute Viral Hepatitis A
integer
C0276434 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
1. Acute Viral Hepatitis A
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
2. Chronic Hepatitis B
integer
C0524909 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
2. Chronic Hepatitis B
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
3. Chronic Hepatitis C
integer
C0524910 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
3. Chronic Hepatitis C
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
4. Cytomegalovirus Hepatitis
integer
C0276252 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
4. Cytomegalovirus Hepatitis
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
5. Epstein Barr Virus Infectious Mononucleosis
integer
C0021345 (UMLS CUI [1,1])
C0014644 (UMLS CUI [1,2])
Acute Viral Hepatitis A
Code List
5. Epstein Barr Virus Infectious Mononucleosis
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
6. Herpes Simplex Hepatitis
integer
C1963747 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
6. Herpes Simplex Hepatitis
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
7. Alcoholic Liver Disease
integer
C0023896 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
7. Alcoholic Liver Disease
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
8. Non-alcoholic Steatohepatitis
integer
C3241937 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
8. Non-alcoholic Steatohepatitis
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
9. Fatty Liver
integer
C0015695 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
9. Fatty Liver
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
10. Hepatic Cirrhosis
integer
C0023890 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
10. Hepatic Cirrhosis
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
11. Hemochromatosis
integer
C0018995 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
11. Hemochromatosis
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
12. Autoimmune Hepatitis
integer
C0241910 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
12. Autoimmune Hepatitis
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
13. Gallbladder disease or biliary disease
integer
C0016977 (UMLS CUI [1])
C3275124 (UMLS CUI [2])
Acute Viral Hepatitis A
Code List
13. Gallbladder disease or biliary disease
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item Group
Drug related liver disease conditions (All drugs including Investigational Product)
C0023895 (UMLS CUI-1)
C0277579 (UMLS CUI-2)
Item
14. Drug related liver disease
integer
C0023895 (UMLS CUI [1,1])
C0277579 (UMLS CUI [1,2])
Acute Viral Hepatitis A
Code List
14. Drug related liver disease
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item Group
Other liver disease conditions
Sequence Number
Item
15.a Sequence Number
text
C2348184 (UMLS CUI [1])
Specific Condition
Item
15. Specific Condition
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Modified Term
Item
15.c Modified Term
text
C2826302 (UMLS CUI [1])
MedDRA Synonym
Item
MedDRA Synonym
text
C1140263 (UMLS CUI [1])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C2347090 (UMLS CUI [1])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Item
15.d Status
integer
C0449438 (UMLS CUI [1])
Status
Code List
15.d Status
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
Item Group
Other medical conditions
Item
16. Drug Allergies
integer
C0013182 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
16. Drug Allergies
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
17. Rheumatoid Arthritis
integer
C0003873 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
17. Rheumatoid Arthritis
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
18. Psoriasis
integer
C0033860 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
18. Psoriasis
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
19. Thyroid Disease
integer
C0040128 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
19. Thyroid Disease
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
20. Inflammatory Bowel Disease
integer
C0021390 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
20. Inflammatory Bowel Disease
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
21. Lupus
integer
C0409974 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
21. Lupus
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
22. Sjogren's Syndrome
integer
C1527336 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
22. Sjogren's Syndrome
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
23. Vitiligo
integer
C0042900 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
23. Vitiligo
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
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