drugset / Trial / NCT02705963
A Drug-Drug Interaction Study to Assess the Effect of Trametinib on the Pharmacokinetics of an Oral Contraceptive in Female Patients With Solid Tumors
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the effect of trametinib once daily on the pharmacokinetics (PK) of a daily dosing oral contraceptives (OCs) containing norethindrone (NE) and ethinyl estradiol (EE) in female patients with solid tumors. The PK of trametinib and its metabolite M5 will also be assessed.
Timeline
- Start
- 2016-10-20
- Primary completion
- 2019-08-29
- Completion
- 2019-08-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Norethindrone | Unknown | 1 mg | Oral |
| Subject | Trametinib | Small molecule | 0.5 mg | Oral |
| Subject | Trametinib | Small molecule | 2 mg | Oral |
| Subject | ethinyl estradiol | Small molecule | 0.035 mg | Oral |