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

A Phase I, Open-Label Study to Determine the Effect of Repeat Dosing of Trametinib on the Pharmacokinetics of a Combined Oral Contraceptive (Norethindrone Plus Ethinyl Estradiol) in Female Patients With Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	Trametinib	Each tablet is 2mg trametinib to be taken orally once daily.
DRUG	Trametinib	Each tablet is 0.5mg trametinib to be taken orally once daily. 0.5mg tablets may be used if a dose reduction is required.
DRUG	Oral Contraceptive (1mg norethindrone, 0.035mg ethinyl estradiol)	Combined oral contraceptive to be taken orally once daily.

Timeline

• Start date: 2016-10-20
• Primary completion: 2019-08-29
• Completion: 2019-08-29
• First posted: 2016-03-11
• Last updated: 2022-02-09

Locations

7 sites across 5 countries: United States, Belgium, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study