A Drug-Drug Interaction Study to Assess the Effect of Trametinib on the Pharmacokinetics of an Oral Contraceptive in Female Patients With Solid Tumors

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02705963
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumors

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 59 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 20, 2016
Status verified
Oct 2021
Primary completion
Aug 29, 2019
Completion
Aug 29, 2019

Study Design

Enrollment
19 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Oral Contraceptive / Trametinib
    In treatment period 1 of the PK Phase patients will take the Oral Contraceptive once daily from Days 1-5. Period 2 of the PK Phase starts on Day 6 when patients take both the Oral Contraceptive and trametinib once daily from Days 6 to 21. Patients may continue dosing with trametinib only once daily from Day 22 onwards (post PK Phase).

Primary Outcome Measure

Pharmacokinetics parameter: AUCtau of NE and EE alone and in combination with trametinib [ Time Frame: Day 5 and 6 and 21 and 22 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Karmanos Cancer Institute Karmanos Cancer InstituteDetroitMichigan48201-
University of OklahomaOklahoma CityOklahoma73104-

Find similar trials in Detroit, MI

By research site
Karmanos Cancer Institute Karmanos Cancer Institute· Detroit, MIUniversity of Oklahoma· Oklahoma City, OK

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