Renal Cell Carcinoma Clinical Trial
Official title:
A Phase 1 Drug-Drug Interaction Study of the Effects of XL184 on the Pharmacokinetics of a Single Oral Dose of Rosiglitazone in Subjects With Solid Tumors
The primary objective of this clinical study is to determine whether the inhibition of
cytochrome P450 (CYP) isozyme CYP2C8 by XL184 observed in in vitro preclinical studies
translates into the potential for clinically significant drug-drug interactions in humans.
The study will measure the effect of once daily dosing of XL184 on the pharmacokinetics (PK)
of rosiglitazone. The PK of XL184 when combined with rosiglitazone will be evaluated as
well.
A specific objective of this study is to determine whether the interaction between XL184 and
a drug such as rosiglitazone is sufficiently large enough to necessitate a dosage adjustment
when used in combination with XL184, or whether the interaction would require additional
therapeutic monitoring.
Rosiglitazone, commonly known as Avandia, is a prescription medicine approved by the FDA
used to treat adults with Type 2 (adult-onset or non-insulin dependent) diabetes mellitus
(high blood sugar). In this study, subjects will only take 2 doses of rosiglitazone. There
is no intention of therapy as a result of taking rosiglitazone in this study.
n/a
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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