ID

40329

Description

Study ID: 111314 Clinical Study ID: 111314 Study Title: A first-time-in-human, three-part, placebo-controlled, dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1521498 in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00857883 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1521498 or placebo Study Indication: Obesity

Keywords

Versions (1)
  1. 4/9/20 4/9/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 9, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1521498 in healthy subjects NCT00857883

English

Summary Study conclusion; Ethnicity; Liver Events; Pregnancy Test; Alcohol Breath Test; Drug Screen

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Study
Description

Study

Data type

text

Alias
UMLS CUI [1]
C2603343
Subject
Description

Subject

Data type

text

Alias
UMLS CUI [1]
C0681850
Collected by
Description

Collected by

Data type

text

Alias
UMLS CUI [1]
C3244127
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Study Phase
Description

Study Phase

Data type

text

Alias
UMLS CUI [1,1]
C0205390
UMLS CUI [1,2]
C2603343
Session
Description

Session

Data type

text

Alias
UMLS CUI [1]
C1883017
Study Completion
Description

Study Completion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Did the patient complete the study as planned?
Description

Did the patient complete the study as planned?

Data type

text

Alias
UMLS CUI [1,1]
C0805732
UMLS CUI [1,2]
C0008972
If patient did not complete the study as planned, select the most appropriate category
Description

If patient did not complete the study as planned, select the most appropriate category

Data type

integer

Alias
UMLS CUI [1,1]
C0805732
UMLS CUI [1,2]
C0008972
UMLS CUI [2]
C0683312
Comments on reason for withdrawal:
Description

Comments on reason for withdrawal:

Data type

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0947611
Date of withdrawal
Description

Date of withdrawal

Data type

date

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0011008
Time of withdrawal
Description

Time of withdrawal

Data type

time

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0040223
Investigator signature
Description

Investigator signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Ethnicity
Description

Ethnicity

Alias
UMLS CUI-1
C0015031
Ethnicity- Physical Date
Description

Ethnicity- Physical Date

Data type

date

Alias
UMLS CUI [1,1]
C0015031
UMLS CUI [1,2]
C0011008
Ethnicity - Time
Description

Ethnicity - Time

Data type

time

Alias
UMLS CUI [1,1]
C0015031
UMLS CUI [1,2]
C0040223
Ethnicity - Day
Description

Ethnicity - Day

Data type

text

Alias
UMLS CUI [1,1]
C0015031
UMLS CUI [1,2]
C0439228
Ethnicity - Hour
Description

Ethnicity - Hour

Data type

integer

Measurement units
  • h
Alias
UMLS CUI [1,1]
C0015031
UMLS CUI [1,2]
C0439227
h
Ethnicity - Min
Description

Ethnicity - Min

Data type

integer

Measurement units
  • min
Alias
UMLS CUI [1,1]
C0015031
UMLS CUI [1,2]
C0439232
min
Ethnicity
Description

Ethnicity

Data type

integer

Alias
UMLS CUI [1]
C0015031
Liver Events
Description

Liver Events

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
Liver Events - Physical Date
Description

Liver Events - Physical Date

Data type

date

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0011008
Liver Events - Time
Description

Liver Events - Time

Data type

time

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0040223
Liver Events - Day
Description

Liver Events - Day

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0439228
Liver Events - Hour
Description

Liver Events - Hour

Data type

integer

Measurement units
  • h
Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0439227
h
Liver Events - Min
Description

Liver Events - Min

Data type

integer

Measurement units
  • min
Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0439232
min
Have liver chemistry results exceeded protocol defined investigational product stopping criteria?
Description

If Yes complete paper liver events form

Data type

text

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0587081
UMLS CUI [1,4]
C0304229
UMLS CUI [1,5]
C2746065
UMLS CUI [1,6]
C0243161
Pregnancy Test
Description

Pregnancy Test

Alias
UMLS CUI-1
C0032976
Pregnancy Test - Physical Date
Description

Pregnancy Test - Physical Date

Data type

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Pregnancy Test - Time
Description

Pregnancy Test - Time

Data type

time

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0040223
Pregnancy Test - Day
Description

Pregnancy Test - Day

Data type

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0439228
Pregnancy Test - Hour
Description

Pregnancy Test - Hour

Data type

integer

Measurement units
  • h
Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0439227
h
Pregnancy Test - Min
Description

Pregnancy Test - Min

Data type

integer

Measurement units
  • min
Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0439232
min
Date Pregnancy Test Performed
Description

Date Pregnancy Test Performed

Data type

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Time Pregnancy Test Performed
Description

Time Pregnancy Test Performed

Data type

time

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0040223
Sample Type
Description

Sample Type

Data type

text

Alias
UMLS CUI [1]
C2347029
Pregnancy Test Result
Description

Pregnancy Test Result

Data type

text

Alias
UMLS CUI [1]
C0427777
Partner Pregnancy Information
Description

Partner Pregnancy Information

Alias
UMLS CUI-1
C0919624
UMLS CUI-2
C1533716
Partner Pregnancy Information - Physical Date
Description

Partner Pregnancy Information - Physical Date

Data type

date

Alias
UMLS CUI [1,1]
C0919624
UMLS CUI [1,2]
C1533716
UMLS CUI [1,3]
C0011008
Partner Pregnancy Information - Time
Description

Partner Pregnancy Information - Time

Data type

time

Alias
UMLS CUI [1,1]
C0919624
UMLS CUI [1,2]
C1533716
Partner Pregnancy Information - Day
Description

Partner Pregnancy Information - Day

Data type

text

Alias
UMLS CUI [1,1]
C0919624
UMLS CUI [1,2]
C1533716
UMLS CUI [1,3]
C0439228
Partner Pregnancy Information - Hour
Description

Partner Pregnancy Information - Hour

Data type

integer

Measurement units
  • h
Alias
UMLS CUI [1,1]
C0919624
UMLS CUI [1,2]
C1533716
UMLS CUI [1,3]
C0439227
h
Partner Pregnancy Information - Min
Description

Partner Pregnancy Information - Min

Data type

integer

Measurement units
  • min
Alias
UMLS CUI [1,1]
C0919624
UMLS CUI [1,2]
C1533716
UMLS CUI [1,3]
C0439232
min
Did a female partner of a male volunteer become pregnant during the study?
Description

Did a female partner of a male volunteer become pregnant during the study?

Data type

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0682323
UMLS CUI [1,3]
C1533716
UMLS CUI [1,4]
C0919624
Alcohol Breath Test
Description

Alcohol Breath Test

Alias
UMLS CUI-1
C0202306
Alcohol Breath Test - Physical Date
Description

Alcohol Breath Test - Physical Date

Data type

date

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C0011008
Alcohol Breath Test - Time
Description

Alcohol Breath Test - Time

Data type

time

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C0040223
Alcohol Breath Test - Day
Description

Alcohol Breath Test - Day

Data type

text

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C0439228
Alcohol Breath Test - Hour
Description

Alcohol Breath Test - Hour

Data type

integer

Measurement units
  • h
Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C0439227
h
Alcohol Breath Test - Min
Description

Alcohol Breath Test - Min

Data type

integer

Measurement units
  • min
Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C0439232
min
Alcohol Breath Test - Date Test Performed
Description

Alcohol Breath Test - Date Test Performed

Data type

date

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C2826247
Alcohol Breath Test - Time Test Performed
Description

Alcohol Breath Test - Time Test Performed

Data type

time

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C0429928
Alcohol Breath Test - Result
Description

Alcohol Breath Test - Result

Data type

text

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C1274040
Drug Screen
Description

Drug Screen

Alias
UMLS CUI-1
C0373483
Drug Screen - Physical Date
Description

Drug Screen - Physical Date

Data type

date

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0011008
Drug Screen - Time
Description

Drug Screen - Time

Data type

time

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0040223
Drug Screen - Day
Description

Drug Screen - Day

Data type

text

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0439228
Drug Screen - Hour
Description

Drug Screen - Hour

Data type

integer

Measurement units
  • h
Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0439227
h
Drug Screen - Min
Description

Drug Screen - Min

Data type

integer

Measurement units
  • min
Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0439232
min
Drug Screen - Date Test Performed
Description

Drug Screen - Date Test Performed

Data type

date

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C2826247
Drug Screen - Time Test Performed
Description

Drug Screen - Time Test Performed

Data type

time

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0429928
Were there any contra-indicated drugs detected
Description

Were there any contra-indicated drugs detected

Data type

text

Alias
UMLS CUI [1,1]
C1511790
UMLS CUI [1,2]
C3845816
Drugs detected
Description

Drugs detected

Data type

text

Alias
UMLS CUI [1,1]
C1511790
UMLS CUI [1,2]
C3845816
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Similar models

Summary Study conclusion; Ethnicity; Liver Events; Pregnancy Test; Alcohol Breath Test; Drug Screen

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Study
Item
Study
text
C2603343 (UMLS CUI [1])
Subject
Item
Subject
text
C0681850 (UMLS CUI [1])
Collected by
Item
Collected by
text
C3244127 (UMLS CUI [1])
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Study Phase
Item
Study Phase
text
C0205390 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
Session
Item
Session
text
C1883017 (UMLS CUI [1])
Item Group
Study Completion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Item
Did the patient complete the study as planned?
text
C0805732 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
Did the patient complete the study as planned?
Code List
Did the patient complete the study as planned?
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not applicable (X)
CL Item
Yes (Y)
Item
If patient did not complete the study as planned, select the most appropriate category
integer
C0805732 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0683312 (UMLS CUI [2])
If patient did not complete the study as planned, select the most appropriate category
Code List
If patient did not complete the study as planned, select the most appropriate category
CL Item
Adverse Event  (1)
CL Item
Lack of efficacy  (2)
CL Item
Protocol deviation  (3)
CL Item
Subject reached protocol defined stopping criteria  (4)
CL Item
Study closed/terminated  (5)
CL Item
Lost to follow-up  (6)
CL Item
Investigator discretion  (7)
CL Item
Withdrew consent (8)
Comments on reason for withdrawal:
Item
Comments on reason for withdrawal:
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Date of withdrawal
Item
Date of withdrawal
date
C2349954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of withdrawal
Item
Time of withdrawal
time
C2349954 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Item Group
Ethnicity
C0015031 (UMLS CUI-1)
Ethnicity- Physical Date
Item
Ethnicity- Physical Date
date
C0015031 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Ethnicity - Time
Item
Ethnicity - Time
time
C0015031 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Ethnicity - Day
Item
Ethnicity - Day
text
C0015031 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Ethnicity - Hour
Item
Ethnicity - Hour
integer
C0015031 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
Ethnicity - Min
Item
Ethnicity - Min
integer
C0015031 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item Group
Liver Events
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Liver Events - Physical Date
Item
Liver Events - Physical Date
date
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Liver Events - Time
Item
Liver Events - Time
time
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Liver Events - Day
Item
Liver Events - Day
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
Liver Events - Hour
Item
Liver Events - Hour
integer
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,3])
Liver Events - Min
Item
Liver Events - Min
integer
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,3])
Item
Have liver chemistry results exceeded protocol defined investigational product stopping criteria?
text
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2746065 (UMLS CUI [1,5])
C0243161 (UMLS CUI [1,6])
Have liver chemistry results exceeded protocol defined investigational product stopping criteria?
Code List
Have liver chemistry results exceeded protocol defined investigational product stopping criteria?
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not applicable (X)
CL Item
Yes (Y)
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
Pregnancy Test - Physical Date
Item
Pregnancy Test - Physical Date
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Pregnancy Test - Time
Item
Pregnancy Test - Time
time
C0032976 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Pregnancy Test - Day
Item
Pregnancy Test - Day
text
C0032976 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Pregnancy Test - Hour
Item
Pregnancy Test - Hour
integer
C0032976 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
Pregnancy Test - Min
Item
Pregnancy Test - Min
integer
C0032976 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
Date Pregnancy Test Performed
Item
Date Pregnancy Test Performed
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time Pregnancy Test Performed
Item
Time Pregnancy Test Performed
time
C0032976 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Sample Type
text
C2347029 (UMLS CUI [1])
Sample Type
Code List
Sample Type
CL Item
Serum (Serum)
CL Item
Urine (Urine)
Item
Pregnancy Test Result
text
C0427777 (UMLS CUI [1])
Pregnancy Test Result
Code List
Pregnancy Test Result
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item Group
Partner Pregnancy Information
C0919624 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Partner Pregnancy Information - Physical Date
Item
Partner Pregnancy Information - Physical Date
date
C0919624 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Partner Pregnancy Information - Time
Item
Partner Pregnancy Information - Time
time
C0919624 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
Partner Pregnancy Information - Day
Item
Partner Pregnancy Information - Day
text
C0919624 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
Partner Pregnancy Information - Hour
Item
Partner Pregnancy Information - Hour
integer
C0919624 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,3])
Partner Pregnancy Information - Min
Item
Partner Pregnancy Information - Min
integer
C0919624 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,3])
Item
Did a female partner of a male volunteer become pregnant during the study?
text
C0032961 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C1533716 (UMLS CUI [1,3])
C0919624 (UMLS CUI [1,4])
Did a female partner of a male volunteer become pregnant during the study?
Code List
Did a female partner of a male volunteer become pregnant during the study?
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not applicable (X)
CL Item
Yes (Y)
Item Group
Alcohol Breath Test
C0202306 (UMLS CUI-1)
Alcohol Breath Test - Physical Date
Item
Alcohol Breath Test - Physical Date
date
C0202306 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Alcohol Breath Test - Time
Item
Alcohol Breath Test - Time
time
C0202306 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Alcohol Breath Test - Day
Item
Alcohol Breath Test - Day
text
C0202306 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Alcohol Breath Test - Hour
Item
Alcohol Breath Test - Hour
integer
C0202306 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
Alcohol Breath Test - Min
Item
Alcohol Breath Test - Min
integer
C0202306 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
Alcohol Breath Test - Date Test Performed
Item
Alcohol Breath Test - Date Test Performed
date
C0202306 (UMLS CUI [1,1])
C2826247 (UMLS CUI [1,2])
Alcohol Breath Test - Time Test Performed
Item
Alcohol Breath Test - Time Test Performed
time
C0202306 (UMLS CUI [1,1])
C0429928 (UMLS CUI [1,2])
Item
Alcohol Breath Test - Result
text
C0202306 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Alcohol Breath Test - Result
Code List
Alcohol Breath Test - Result
CL Item
Negative (Negative)
CL Item
Positive (Positive)
Item Group
Drug Screen
C0373483 (UMLS CUI-1)
Drug Screen - Physical Date
Item
Drug Screen - Physical Date
date
C0373483 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Drug Screen - Time
Item
Drug Screen - Time
time
C0373483 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Drug Screen - Day
Item
Drug Screen - Day
text
C0373483 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Drug Screen - Hour
Item
Drug Screen - Hour
integer
C0373483 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
Drug Screen - Min
Item
Drug Screen - Min
integer
C0373483 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
Drug Screen - Date Test Performed
Item
Drug Screen - Date Test Performed
date
C0373483 (UMLS CUI [1,1])
C2826247 (UMLS CUI [1,2])
Drug Screen - Time Test Performed
Item
Drug Screen - Time Test Performed
time
C0373483 (UMLS CUI [1,1])
C0429928 (UMLS CUI [1,2])
Item
Were there any contra-indicated drugs detected
text
C1511790 (UMLS CUI [1,1])
C3845816 (UMLS CUI [1,2])
Were there any contra-indicated drugs detected
Code List
Were there any contra-indicated drugs detected
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not applicable (X)
CL Item
Yes (Y)
Drugs detected
Item
Drugs detected
text
C1511790 (UMLS CUI [1,1])
C3845816 (UMLS CUI [1,2])
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