Study Subject Participation Status | Protocol Specified
Item
1) only subjects who are eligible for and have entered into protocol tde-ph-304 may participate in this substudy.
boolean
C2348568 (UMLS CUI [1])
C2348563 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Informed Consent Voluntary
Item
1. the subject must voluntarily give informed consent to participate in the substudy.
boolean
C0021430 (UMLS CUI [1,1])
C0439656 (UMLS CUI [1,2])
Investigational New Drugs Dose Change
Item
2. no dose changes to study drug are made within 5 days of the pharmacokinetic (pk)substudy visits.
boolean
C0013230 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
Pharmaceutical Preparations Additional | Pharmaceutical Preparations Discontinuation | Diuretics Change allowed | Anticoagulants Change allowed
Item
3. no additions or deletions to concurrent medications are made within 7 days of the pharmacokinetic substudy visit. note: changes to diuretics and/or anticoagulants are permitted.
boolean
C0013227 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0012798 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C0003280 (UMLS CUI [4,1])
C0392747 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Investigational New Drug Level | Evening Dose | Morning Dose | Pharmacokinetics Sampling
Item
4. the preceding evening dose of study drug should have been taken 9 to 13 hours prior to the bid dose and 6-10 hours prior to the tid morning dose of study drug to ensure a trough level of study drug for pk sampling.
boolean
C0013230 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
C0587117 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0332170 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0031328 (UMLS CUI [4,1])
C0870078 (UMLS CUI [4,2])
Investigational New Drug Dosage | Pharmacokinetics Sampling
Item
5. subject dosing of study drug on the day of pk sampling must be observed in the clinic by study personnel.
boolean
C0013230 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0031328 (UMLS CUI [2,1])
C0870078 (UMLS CUI [2,2])
Blood Loss Amount
Item
6. subject has not experienced a significant loss of blood (> 450 ml) within the last 6 weeks of the pharmacokinetic substudy visit.
boolean
C3163616 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
CYP2C8 Inducers | CYP2C8 Inhibitors
Item
7. the subject must not be receiving any cyp 2c8 inducers or inhibitors
boolean
C3850048 (UMLS CUI [1])
C3850061 (UMLS CUI [2])