ID
33841
Description
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2
Keywords
Versions (1)
- 1/3/19 1/3/19 -
Copyright Holder
GSK group of companies
Uploaded on
January 3, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032
Liver Event Assessments
- StudyEvent: ODM
Description
Liver Events Assessment
Description
If Yes, stop investigational product, complete date stopped on Investigational Product form, contact GSK within 24 hours of occurrence, complete Liver Events Form and obtain the following test: 1.Blood sample for PK analysis, obtained within three half-lives(21 days) of last dose; 2.Hepatitis A: IgM antibody; 3, Hepatitis B surface antigen and Core Antibody (IgM); 4. Hepatitis C: RNA; 5.Hepatitis E IgM antibody (if subject resides or has travelled in past 3 month outside the USA or Canada); 6. Cytomegalovirus IgM antibody (CMV); 7. EBV (Epstein Barr Viral capsid antigen IgM antibody)or if unavailable, obtain heterophile antibody or monospot testing; 8.CPK (Serum creatine phosphokinase); 9. LDH (lactate dehydrogenase); 10. Bilirubin fractionation, if bilirubin >=1.5xULN (If ALT >=3xULN and bilirubin >1.5xULN(>35% direct), the following are needed: anti-nuclear antibody, anti-smooth muscle antibody, tape 1 anti-liver kidney microsomal antibodies, liver imaging).
Data type
boolean
Description
Liver Events
Description
SAE / AE reference number
Data type
integer
Description
Date of assessment
Data type
date
Description
check all that apply
Data type
text
Description
If Other, specify
Data type
text
Description
Is the subject 55 or older?
Data type
boolean
Description
if Yes, complete the Pregnancy Notification Form
Data type
text
Description
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as a liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
Data type
boolean
Description
if No, record the details on the Non-Serious Adverse Events form or Serious Adverse Events form.
Data type
boolean
Description
Were any liver biopsies performed?
Data type
boolean
Description
If Yes, record on the appropriate Concomitant Medication form
Data type
boolean
Description
Did the subject fast or undergo significant dietary change in the past week?
Data type
boolean
Description
An unscheduled PK blood sample must be obtained within three half-lives (21 days) of last dose.
Data type
boolean
Description
Date of sample taken
Data type
date
Description
Time of sample taken
Data type
time
Description
Record date and time of last investigational product dose prior to PK sample (if administered at subject's home, please do not record the time)
Data type
datetime
Description
Alcohol Intake
Description
Liver Disease Medical Conditions
Description
1. Acute viral Hepatitis A
Data type
text
Description
2. Chronic Hepatitis B
Data type
text
Description
3. Chronic Hepatitis C
Data type
text
Description
4. Cytomegalovirus Hepatitis
Data type
text
Description
5. Epstein Barr virus infectious mononucleosis
Data type
text
Description
6. Herpes Simplex Hepatitis
Data type
text
Description
7. Alcoholic liver disease
Data type
text
Description
8. Non-alcoholic steatohepatitis
Data type
text
Description
9. Fatty Liver
Data type
text
Description
10. Hepatic Cirrhosis
Data type
text
Description
11. Hemochromatosis
Data type
text
Description
12. Autoimmune Hepatitis
Data type
text
Description
13. Gallbladder disease or biliary disease
Data type
text
Description
Drug Related Liver Disease Conditions
Description
specify here
Data type
text
Description
Status of condition
Data type
text
Description
15. Specific condition
Data type
text
Description
Status of condition
Data type
text
Description
15. Specific condition
Data type
text
Description
Status of condition
Data type
text
Description
Other Medical Conditions
Description
17. Drug allergies
Data type
text
Description
18. Rheumatoid Arthritis
Data type
text
Description
19. Psoriasis
Data type
text
Description
20. Thyroid disease
Data type
text
Description
21. Inflammatory bowel disease
Data type
text
Description
22. Lupus
Data type
text
Description
23. Sjoren's syndrome
Data type
text
Description
24. Vitiligo
Data type
text
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Liver Event Assessments
- StudyEvent: ODM