Trial Outcomes & Findings for Study Evaluating the Drug Interaction Potential of Luliconazole Cream 1% in Participants With Tinea Pedis and Tinea Cruris (NCT NCT02394340)

Last Updated: 2019-11-27

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

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

Results posted on

2019-11-27

Participant Flow

Participant milestones

Participant milestones
Measure	Luliconazole Cream 1% Participants received 1 oral capsule of omeprazole 40 milligrams (mg) on Day 1 and Day 8. Participants also received 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.
Overall Study STARTED	20
Overall Study Received at Least 1 Dose of Study Drug	20
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Luliconazole Cream 1% Participants received 1 oral capsule of omeprazole 40 milligrams (mg) on Day 1 and Day 8. Participants also received 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.
Overall Study Failed drug screen test	1
Overall Study Adverse Event	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Luliconazole Cream 1% n=20 Participants Participants received 1 oral capsule of omeprazole 40 mg on Day 1 and Day 8. Participants also received 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.
Age, Continuous	45.05 years STANDARD_DEVIATION 10.47 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Population: Randomized participants who received at least 1 dose of study drug and had evaluable data at the specified time point.

Outcome measures

Outcome measures
Measure	Luliconazole Cream 1% n=20 Participants Participants received 1 oral capsule of omeprazole 40 mg on Day 1 and Day 8. Participants also received 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.
Circulating Levels (Plasma Concentration) of Omeprazole Prior to Treatment With Luliconazole Cream 1% 8 hours postdose	129.70 ng/mL Standard Deviation 129.08
Circulating Levels (Plasma Concentration) of Omeprazole Prior to Treatment With Luliconazole Cream 1% 10 hours postdose	74.24 ng/mL Standard Deviation 84.54
Circulating Levels (Plasma Concentration) of Omeprazole Prior to Treatment With Luliconazole Cream 1% Predose	0 ng/mL Standard Deviation 0
Circulating Levels (Plasma Concentration) of Omeprazole Prior to Treatment With Luliconazole Cream 1% 15 minutes postdose	0 ng/mL Standard Deviation 0
Circulating Levels (Plasma Concentration) of Omeprazole Prior to Treatment With Luliconazole Cream 1% 30 minutes postdose	23.67 ng/mL Standard Deviation 89.46
Circulating Levels (Plasma Concentration) of Omeprazole Prior to Treatment With Luliconazole Cream 1% 45 minutes postdose	196.30 ng/mL Standard Deviation 301.31
Circulating Levels (Plasma Concentration) of Omeprazole Prior to Treatment With Luliconazole Cream 1% 1 hour postdose	463.74 ng/mL Standard Deviation 546.51
Circulating Levels (Plasma Concentration) of Omeprazole Prior to Treatment With Luliconazole Cream 1% 1.5 hours postdose	526.98 ng/mL Standard Deviation 499.60
Circulating Levels (Plasma Concentration) of Omeprazole Prior to Treatment With Luliconazole Cream 1% 2 hours postdose	655.70 ng/mL Standard Deviation 520.31
Circulating Levels (Plasma Concentration) of Omeprazole Prior to Treatment With Luliconazole Cream 1% 2.5 hours postdose	621.08 ng/mL Standard Deviation 464.55
Circulating Levels (Plasma Concentration) of Omeprazole Prior to Treatment With Luliconazole Cream 1% 3 hours postdose	636.60 ng/mL Standard Deviation 508.53
Circulating Levels (Plasma Concentration) of Omeprazole Prior to Treatment With Luliconazole Cream 1% 4 hours postdose	468.79 ng/mL Standard Deviation 355.49
Circulating Levels (Plasma Concentration) of Omeprazole Prior to Treatment With Luliconazole Cream 1% 6 hours postdose	235.20 ng/mL Standard Deviation 214.29
Circulating Levels (Plasma Concentration) of Omeprazole Prior to Treatment With Luliconazole Cream 1% 24 hours postdose	3.32 ng/mL Standard Deviation 6.18

PRIMARY outcome

Timeframe: 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

Population: Randomized participants who received at least 1 dose of study drug and had evaluable data at the specified time point.

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).

Outcome measures

Outcome measures
Measure	Luliconazole Cream 1% n=18 Participants Participants received 1 oral capsule of omeprazole 40 mg on Day 1 and Day 8. Participants also received 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.
Circulating Levels (Plasma Concentration) of Omeprazole After 1 Week of Treatment With Luliconazole Cream 1% 45 minutes postdose	142.72 ng/mL Standard Deviation 298.29
Circulating Levels (Plasma Concentration) of Omeprazole After 1 Week of Treatment With Luliconazole Cream 1% 2 hours postdose	763.51 ng/mL Standard Deviation 607.80
Circulating Levels (Plasma Concentration) of Omeprazole After 1 Week of Treatment With Luliconazole Cream 1% Predose	0 ng/mL Standard Deviation 0
Circulating Levels (Plasma Concentration) of Omeprazole After 1 Week of Treatment With Luliconazole Cream 1% 15 minutes postdose	0 ng/mL Standard Deviation 0
Circulating Levels (Plasma Concentration) of Omeprazole After 1 Week of Treatment With Luliconazole Cream 1% 30 minutes postdose	18.11 ng/mL Standard Deviation 68.24
Circulating Levels (Plasma Concentration) of Omeprazole After 1 Week of Treatment With Luliconazole Cream 1% 1 hour postdose	317.21 ng/mL Standard Deviation 401.97
Circulating Levels (Plasma Concentration) of Omeprazole After 1 Week of Treatment With Luliconazole Cream 1% 1.5 hours postdose	637.56 ng/mL Standard Deviation 509.09
Circulating Levels (Plasma Concentration) of Omeprazole After 1 Week of Treatment With Luliconazole Cream 1% 2.5 hours postdose	700.91 ng/mL Standard Deviation 423.74
Circulating Levels (Plasma Concentration) of Omeprazole After 1 Week of Treatment With Luliconazole Cream 1% 3 hours postdose	730.56 ng/mL Standard Deviation 349.10
Circulating Levels (Plasma Concentration) of Omeprazole After 1 Week of Treatment With Luliconazole Cream 1% 4 hours postdose	586.83 ng/mL Standard Deviation 309.83
Circulating Levels (Plasma Concentration) of Omeprazole After 1 Week of Treatment With Luliconazole Cream 1% 6 hours postdose	323.40 ng/mL Standard Deviation 219.50
Circulating Levels (Plasma Concentration) of Omeprazole After 1 Week of Treatment With Luliconazole Cream 1% 8 hours postdose	190.15 ng/mL Standard Deviation 154.82
Circulating Levels (Plasma Concentration) of Omeprazole After 1 Week of Treatment With Luliconazole Cream 1% 10 hours postdose	111.51 ng/mL Standard Deviation 102.30
Circulating Levels (Plasma Concentration) of Omeprazole After 1 Week of Treatment With Luliconazole Cream 1% 24 hours postdose	6.84 ng/mL Standard Deviation 10.01

Adverse Events

Luliconazole Cream 1%

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Luliconazole Cream 1% n=20 participants at risk Participants received 1 oral capsule of omeprazole 40 mg on Day 1 and Day 8. Participants also received 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.
Injury, poisoning and procedural complications Muscle strain	5.0% 1/20 • Baseline up to Day 9 All participants who received at least 1 application of study drug and had at least 1 post-Baseline assessment.
Investigations Alanine aminotransferase increased	5.0% 1/20 • Baseline up to Day 9 All participants who received at least 1 application of study drug and had at least 1 post-Baseline assessment.
Investigations Aspartate Aminotransferase increased	5.0% 1/20 • Baseline up to Day 9 All participants who received at least 1 application of study drug and had at least 1 post-Baseline assessment.
Investigations Hemoglobin decreased	5.0% 1/20 • Baseline up to Day 9 All participants who received at least 1 application of study drug and had at least 1 post-Baseline assessment.
Musculoskeletal and connective tissue disorders Back pain	5.0% 1/20 • Baseline up to Day 9 All participants who received at least 1 application of study drug and had at least 1 post-Baseline assessment.

Additional Information

Director of Clinical Operations

Bausch Health Americas, Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Please contact Sponsor directly for additional information.
Publication restrictions are in place

Restriction type: OTHER