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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.

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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

FieldValue
Enrollment Target 19 participants
Start Date 2016-10-20
Est. Completion 2019-08-29
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.