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NCT03451110 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive, Famotidine, or Fluconazole in Healthy Subjects
A Phase 1 study of Healthy Subjects, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT03451110 is a Phase 1 study of Healthy Subjects that has completed, run by Eisai. The registered enrollment target is 50 participants, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03451110, a Phase 1 study of Healthy Subjects, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG fluconazole
- DRUG famotidine
- DRUG lemborexant
- DRUG Loestrin
Study Locations (1)
Texas
- Worldwide Clinical Trials - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2018-02-05 |
| Est. Completion | 2018-03-23 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03451110
The ClinicalTrials.gov registry entry for NCT03451110 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (61% lower). The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy Subjects appearing as the primary indexed condition, and to 4 interventions - of which fluconazole is the first listed.
NCT03451110 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT03451110 about?
NCT03451110 is a clinical study titled "Study to Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive, Famotidine, or Fluconazole in Healthy Subjects". 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 flu...
What is the current status of trial NCT03451110?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2018-02-05. Estimated completion is 2018-03-23.
What conditions does trial NCT03451110 study?
This clinical trial studies the following conditions: Healthy Subjects.
What interventions are being tested in trial NCT03451110?
The interventions under investigation include: fluconazole (DRUG), famotidine (DRUG), lemborexant (DRUG), Loestrin (DRUG).
Who is sponsoring clinical trial NCT03451110?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03451110 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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.