Overview

Study to Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive, Famotidine, or Fluconazole in Healthy Subjects

Status:
Completed

Trial end date:
2018-03-23

Target enrollment:

Participant gender:

Summary

This study will be conducted to evaluate the effect of lemborexant 10 milligrams (mg) (at steady state) on the pharmacokinetics (PK) of a single-dose combined oral contraceptive, Loestrin 1.5/30 (containing 0.030 mg of ethinyl estradiol and 1.5 mg of norethindrone), and to evaluate the effect of fluconazole 200 mg (at steady state) and a single dose of famotidine 40 mg (an H2 blocker) on the PK of a single oral dose of lemborexant 10 mg.

Phase:

Phase 1

Details

Lead Sponsor:

Eisai Inc.

Collaborator:

Purdue Pharma LP

Treatments:

Contraceptive Agents
Contraceptives, Oral
Famotidine
Fluconazole
Lemborexant
Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Norinyl