ID
41635
Description
Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2
Keywords
Versions (2)
- 11/5/20 11/5/20 -
- 11/29/20 11/29/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
November 29, 2020
DOI
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License
Creative Commons BY 4.0
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Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692
Screening - Informed Consent; Admission Criteria; Demographics; Electocardiogram; Central Laboratory
Description
Informed Consent
Alias
- UMLS CUI-1
- C0021430
Description
Admission Criteria
Alias
- UMLS CUI-1
- C0030673
- UMLS CUI-2
- C0243161
Description
Admission Criteria
Alias
- UMLS CUI-1
- C0030673
- UMLS CUI-2
- C0243161
Description
Check one criteria type
Data type
text
Alias
- UMLS CUI [1,1]
- C0243161
- UMLS CUI [1,2]
- C0332307
Description
Criteria Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0243161
- UMLS CUI [1,2]
- C0237753
Description
Waiver Granted?
Data type
boolean
Alias
- UMLS CUI [1]
- C3827528
Description
Date of Sponsor Approval
Data type
date
Alias
- UMLS CUI [1]
- C2346844
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Demographics
Alias
- UMLS CUI-1
- C1704791
Description
Date of Birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Check all that apply.
Data type
integer
Alias
- UMLS CUI [1]
- C0034510
Description
Specify Other Race
Data type
text
Alias
- UMLS CUI [1]
- C0034510
- UMLS CUI [2,1]
- C0205394
- UMLS CUI [2,2]
- C3845569
Description
Mark one.
Data type
integer
Alias
- UMLS CUI [1]
- C0015031
Description
Is the subject of childbearing potential?
Data type
text
Alias
- UMLS CUI [1]
- C3831118
Description
Electrocardiogram
Alias
- UMLS CUI-1
- C0013798
Description
Date ECG Performed
Data type
date
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0011008
Description
Time ECG Performed
Data type
time
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0040223
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
PR Interval
Data type
float
Measurement units
- ms
Alias
- UMLS CUI [1]
- C0429087
Description
QRS Duration
Data type
float
Measurement units
- ms
Alias
- UMLS CUI [1]
- C0429025
Description
QT Interval
Data type
float
Measurement units
- ms
Alias
- UMLS CUI [1]
- C1287082
Description
QTcB Interval
Data type
float
Measurement units
- ms
Alias
- UMLS CUI [1,1]
- C1882512
- UMLS CUI [1,2]
- C0855331
Description
QTcF Interval
Data type
float
Measurement units
- ms
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C1882513
Description
RR Interval
Data type
float
Measurement units
- ms
Alias
- UMLS CUI [1]
- C0489636
Description
Normal Sinus Rhythmus?
Data type
boolean
Alias
- UMLS CUI [1]
- C0232202
Description
Overall interpretation of ECG:
Data type
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0459471
Description
If abnormal, please specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0243095
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C2348235
Description
Central Laboratory - Haematology
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C0018941
Description
Was the laboratory sample collected? (Haematology)
Data type
boolean
Alias
- UMLS CUI [1]
- C0005834
- UMLS CUI [2]
- C0018941
Description
Sample Date (Haematology)
Data type
date
Alias
- UMLS CUI [1]
- C1302413
- UMLS CUI [2]
- C0018941
Description
Sample Time (Haematology)
Data type
time
Alias
- UMLS CUI [1]
- C0005834
- UMLS CUI [2]
- C0040223
- UMLS CUI [3]
- C0018941
Description
Comment (Haematology)
Data type
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2]
- C0018941
Description
Central Laboratory - Chemistry/ Serum HCG/ SP Chem
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C0008000
- UMLS CUI-3
- C0430060
Description
Was the laboratory sample collected? (Chemistry)
Data type
boolean
Alias
- UMLS CUI [1]
- C0005834
- UMLS CUI [2]
- C0008000
Description
Sample Date (Chemistry)
Data type
date
Alias
- UMLS CUI [1]
- C1302413
- UMLS CUI [2]
- C0008000
Description
Sample Time (Chemistry)
Data type
time
Alias
- UMLS CUI [1]
- C0005834
- UMLS CUI [2]
- C0040223
- UMLS CUI [3]
- C0008000
Description
Comment (Chemistry)
Data type
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2]
- C0008000
Description
Central Laboratory - UA/ UDS/ Urine Chem
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C0864414
Description
Was the laboratory sample collected? (Urine)
Data type
boolean
Alias
- UMLS CUI [1]
- C0005834
- UMLS CUI [2]
- C0864414
Description
Sample Date (Urine)
Data type
date
Alias
- UMLS CUI [1]
- C1302413
- UMLS CUI [2]
- C0864414
Description
Sample Time (Urine)
Data type
time
Alias
- UMLS CUI [1]
- C0005834
- UMLS CUI [2]
- C0040223
- UMLS CUI [3]
- C0864414
Description
Comment (Urine)
Data type
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2]
- C0864414
Description
Central Laboratory - Serology
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C0036743
Description
Was the laboratory sample collected? (Serology)
Data type
boolean
Alias
- UMLS CUI [1]
- C0005834
- UMLS CUI [2]
- C0036743
Description
Sample Date (Serology)
Data type
date
Alias
- UMLS CUI [1]
- C1302413
- UMLS CUI [2]
- C0036743
Description
Sample Time (Serology)
Data type
time
Alias
- UMLS CUI [1]
- C0005834
- UMLS CUI [2]
- C0040223
- UMLS CUI [3]
- C0036743
Description
Comment (Serology)
Data type
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2]
- C0036743
Similar models
Screening - Informed Consent; Admission Criteria; Demographics; Electocardiogram; Central Laboratory
C0750479 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C3845569 (UMLS CUI [2,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
C1882513 (UMLS CUI [1,2])
C0459471 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0018941 (UMLS CUI-2)
C0018941 (UMLS CUI [2])
C0018941 (UMLS CUI [2])
C0040223 (UMLS CUI [2])
C0018941 (UMLS CUI [3])
C0018941 (UMLS CUI [2])
C0008000 (UMLS CUI-2)
C0430060 (UMLS CUI-3)
C0008000 (UMLS CUI [2])
C0008000 (UMLS CUI [2])
C0040223 (UMLS CUI [2])
C0008000 (UMLS CUI [3])
C0008000 (UMLS CUI [2])
C0864414 (UMLS CUI-2)
C0864414 (UMLS CUI [2])
C0864414 (UMLS CUI [2])
C0040223 (UMLS CUI [2])
C0864414 (UMLS CUI [3])
C0864414 (UMLS CUI [2])
C0036743 (UMLS CUI-2)
C0036743 (UMLS CUI [2])
C0036743 (UMLS CUI [2])
C0040223 (UMLS CUI [2])
C0036743 (UMLS CUI [3])
C0036743 (UMLS CUI [2])