ID
33841
Beschreibung
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
Stichworte
Versionen (1)
- 03.01.19 03.01.19 -
Rechteinhaber
GSK group of companies
Hochgeladen am
3. Januar 2019
DOI
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Lizenz
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
Beschreibung
Liver Events Assessment
Beschreibung
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).
Datentyp
boolean
Beschreibung
Liver Events
Beschreibung
SAE / AE reference number
Datentyp
integer
Beschreibung
Date of assessment
Datentyp
date
Beschreibung
check all that apply
Datentyp
text
Beschreibung
If Other, specify
Datentyp
text
Beschreibung
Is the subject 55 or older?
Datentyp
boolean
Beschreibung
if Yes, complete the Pregnancy Notification Form
Datentyp
text
Beschreibung
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)?
Datentyp
boolean
Beschreibung
if No, record the details on the Non-Serious Adverse Events form or Serious Adverse Events form.
Datentyp
boolean
Beschreibung
Were any liver biopsies performed?
Datentyp
boolean
Beschreibung
If Yes, record on the appropriate Concomitant Medication form
Datentyp
boolean
Beschreibung
Did the subject fast or undergo significant dietary change in the past week?
Datentyp
boolean
Beschreibung
An unscheduled PK blood sample must be obtained within three half-lives (21 days) of last dose.
Datentyp
boolean
Beschreibung
Date of sample taken
Datentyp
date
Beschreibung
Time of sample taken
Datentyp
time
Beschreibung
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)
Datentyp
datetime
Beschreibung
Alcohol Intake
Beschreibung
Liver Disease Medical Conditions
Beschreibung
1. Acute viral Hepatitis A
Datentyp
text
Beschreibung
2. Chronic Hepatitis B
Datentyp
text
Beschreibung
3. Chronic Hepatitis C
Datentyp
text
Beschreibung
4. Cytomegalovirus Hepatitis
Datentyp
text
Beschreibung
5. Epstein Barr virus infectious mononucleosis
Datentyp
text
Beschreibung
6. Herpes Simplex Hepatitis
Datentyp
text
Beschreibung
7. Alcoholic liver disease
Datentyp
text
Beschreibung
8. Non-alcoholic steatohepatitis
Datentyp
text
Beschreibung
9. Fatty Liver
Datentyp
text
Beschreibung
10. Hepatic Cirrhosis
Datentyp
text
Beschreibung
11. Hemochromatosis
Datentyp
text
Beschreibung
12. Autoimmune Hepatitis
Datentyp
text
Beschreibung
13. Gallbladder disease or biliary disease
Datentyp
text
Beschreibung
Drug Related Liver Disease Conditions
Beschreibung
specify here
Datentyp
text
Beschreibung
Status of condition
Datentyp
text
Beschreibung
15. Specific condition
Datentyp
text
Beschreibung
Status of condition
Datentyp
text
Beschreibung
15. Specific condition
Datentyp
text
Beschreibung
Status of condition
Datentyp
text
Beschreibung
Other Medical Conditions
Beschreibung
17. Drug allergies
Datentyp
text
Beschreibung
18. Rheumatoid Arthritis
Datentyp
text
Beschreibung
19. Psoriasis
Datentyp
text
Beschreibung
20. Thyroid disease
Datentyp
text
Beschreibung
21. Inflammatory bowel disease
Datentyp
text
Beschreibung
22. Lupus
Datentyp
text
Beschreibung
23. Sjoren's syndrome
Datentyp
text
Beschreibung
24. Vitiligo
Datentyp
text
Ähnliche Modelle
Liver Event Assessments
- StudyEvent: ODM