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NCT02705963 · ClinicalTrials.gov registry record · Phase 1
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 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT02705963 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 19 participants.
The verdict
NCT02705963, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study 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.
Interventions
- DRUG Trametinib
- DRUG Oral Contraceptive (1mg norethindrone, 0.035mg ethinyl estradiol)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2016-10-20 |
| Est. Completion | 2019-08-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02705963
The ClinicalTrials.gov registry entry for NCT02705963 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Trametinib is the first listed.
NCT02705963 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02705963 about?
NCT02705963 is a clinical study titled "A Drug-Drug Interaction Study to Assess the Effect of Trametinib on the Pharmacokinetics of an Oral Contraceptive in Female Patients With Solid Tumors". 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...
What is the current status of trial NCT02705963?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2016-10-20. Estimated completion is 2019-08-29.
What interventions are being tested in trial NCT02705963?
The interventions under investigation include: Trametinib (DRUG), Oral Contraceptive (1mg norethindrone, 0.035mg ethinyl estradiol) (DRUG).
Who is sponsoring clinical trial NCT02705963?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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