Study Evaluating the Drug Interaction Potential of Luliconazole Cream 1% in Participants With Tinea Pedis and Tinea Cruris

Phase 4

Completed

Brief Summary: This is an open-label, maximal use study to evaluate whether luliconazole in plasma acts as an inhibitor of cytochrome P2C19 (CYP2C19) as measured by circulating levels of omeprazole before and after treatment with a maximum dose of luliconazole cream 1% in participants with moderate to severe tinea pedis and tinea cruris.

Recruitment & Eligibility

Inclusion Criteria

Participants with a clinical diagnosis of moderate to severe interdigital tinea pedis, as defined by a Physician's Global Assessment (PGA) score of 2 or 3 on both feet, and moderate to severe tinea cruris, as defined by a PGA score of 2 or 3
Participants with a mycological diagnosis of tinea pedis and tinea cruris confirmed by the detection of fungal hyphae on a microscopic potassium hydroxide (KOH) wet mount
Participants must be in good general health and free of any disease that might interfere with study evaluations
Participants with the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study

Exclusion Criteria

Female participants who are pregnant and/or nursing or planning a pregnancy during the course of the trial
Participants who are immunocompromised
Participants who have a recent history of or currently known drug or alcohol abuse
Participants with a history of intolerance or hypersensitivity to imidazole compounds, proton pump inhibitors, or the inactive components of luliconazole cream 1% or omeprazole
Participants with a life-threatening condition within the last 6 months
Participants with uncontrolled diabetes mellitus
Participants who are unable to communicate or cooperate with the Investigator
Participants using medications for treatment of tinea pedis and/or tinea cruris (see Investigator for length of time prior to study start)
Participants receiving concomitant drugs that are known to inhibit and/or induce CYP2C19 and/or CYP3A4, or that interact with omeprazole
Because of the potential for drug interaction with luliconazole, administration with medications that are known to be substrates of CYP3A4, CYP2B6, CYP2C8, and CYP2C19 should be carefully monitored

Arm && Interventions

Group	Intervention	Description
Luliconazole Cream 1%	Omeprazole 40 mg	Participants will receive 1 oral capsule of omeprazole 40 milligrams (mg) on Day 1 and Day 8. Participants will also receive luliconazole cream 1% to cover the entire affected surface areas and adjacent areas once daily in the morning on Day 2 (24 hours after initial omeprazole dosing) through Day 8.
Luliconazole Cream 1%	Luliconazole Cream 1%	Participants will receive 1 oral capsule of omeprazole 40 milligrams (mg) on Day 1 and Day 8. Participants will also receive luliconazole cream 1% to cover the entire affected surface areas and adjacent areas once daily in the morning on Day 2 (24 hours after initial omeprazole dosing) through Day 8.

Primary Outcome Measures

Name	Time	Method
Circulating Levels (Plasma Concentration) of Omeprazole After 1 Week of Treatment With Luliconazole Cream 1%	15 minutes predose; 15, 30, 45, and 60 minutes postdose; and 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours postdose of omeprazole on Day 8	Circulating plasma levels of omeprazole were measured using validated LS/MS-MS methods. The range for omeprazole determination was 4.64-9.27 ng/mL. Serial blood sampling occurred in each enrolled participant up to 24 hours post treatment (Day 8) with omeprazole (after using luliconazole cream 1% treatment for 1 week).
Circulating Levels (Plasma Concentration) of Omeprazole Prior to Treatment With Luliconazole Cream 1%	15 minutes predose; 15, 30, 45, and 60 minutes postdose; and 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours postdose of omeprazole on Day 1	Circulating plasma levels of omeprazole were measured using validated liquid chromatography with tandem mass spectrometry detection (LS/MS-MS) methods. The range for omeprazole determination was 4.64-9.27 nanograms/milliliter (ng/mL). Serial blood sampling occurred in each enrolled participant up to 24 hours post treatment (Day 1) with omeprazole (before the start of luliconazole cream 1% treatment on Day 2).

Secondary Outcome Measures