NCT03451110

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

A 3-Part, Open-label Study to Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive, Famotidine, or Fluconazole in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	lemborexant	oral tablet
DRUG	Loestrin	oral tablet
DRUG	famotidine	oral tablet
DRUG	fluconazole	oral tablet

Timeline

• Start date: 2018-02-05
• Primary completion: 2018-03-23
• Completion: 2018-03-23
• First posted: 2018-03-01
• Last updated: 2018-09-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study