drugset / Trial / NCT03451110
Study to Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive, Famotidine, or Fluconazole in Healthy Subjects
Non-randomizedParallel-groupOpen-labelBasic science
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.
Timeline
- Start
- 2018-02-05
- Primary completion
- 2018-03-23
- Completion
- 2018-03-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Famotidine | Other / unclassified | 40 mg | Oral |
| Subject | Fluconazole | Small molecule | 200 mg | Oral |
| Subject | Lemborexant | Small molecule | 10 mg | Oral |
| Subject | Loestrin | Unknown | 0.03 mg | Oral |
| Subject | Loestrin | Unknown | 1.5 mg | Oral |
Indications
No indication recorded.