Psoriasis
Conditions
Brief summary
This study is known as a drug interaction study. The purpose is to learn about how ixekizumab may affect the blood levels of a mixture of commonly used drugs (caffeine, omeprazole, warfarin, dextromethorphan, and midazolam) that are metabolized by cytochrome P450. Each participant will complete two study periods. Participants will take the mixture of commonly used drugs (plus vitamin K) by mouth on 3 occasions (prior to treatment with ixekizumab and after 1 and 12 weeks of treatment with ixekizumab). The study will last about 17 weeks, including follow-up. Screening must be completed prior to study start.
Interventions
DRUGDrug Cocktail
Administered orally
DRUGIxekizumab
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females with chronic moderate or severe plaque psoriasis for at least 6 months who are candidates for systemic therapy or phototherapy * Men and women of childbearing potential must agree to use a reliable method of birth control and men may not donate sperm for the duration of the study. Women must test negative for pregnancy at screening and agree not to become pregnant during the study and until the first normal period following the end of the study * Have a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m²), inclusive, at screening * Have greater than or equal to (≥) 10 percent body surface area (BSA) involvement at screening and first admission to the clinical research unit (CRU) * Have both a Static Physicians Global Assessment (sPGA) score of ≥3 and Psoriasis Area Severity Index (PASI) score ≥12 at screening and first admission to the CRU
Exclusion criteria
* Forms of psoriasis other than chronic plaque-type * Pregnant or nursing (lactating women) * History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection * Have major surgery within 8 weeks prior to first admission to the clinical research unit or during the study * Have a history of lymphoproliferative disease, or signs or symptoms of lymphoproliferative disease, or have active or history of malignant disease, or have uncontrolled cerebrocardiovascular or neuropsychiatric disease * Require treatment with the cocktail drugs or with inhibitors of cytochrome P450 (CYP) 3A, CYP2C9, CYP2D6, CYP2C19, CYP1A2, or with inducers of CYP3A or CYP1A2, or with rifampin (inducer of multiple CYPs) or with substrates of CYP3A, CYP2C9, CYP2D6, CYP2C19, or CYP1A2 with narrow therapeutic indices within 14 days prior to the first administration of the drug cocktail through the end of Week 12 assessments * Have any known allergy or hypersensitivity to any component of the study cocktail or ixekizumab * Have participated in any other study with ixekizumab, secukinumab or brodalumab, or have been prescribed ixekizumab or secukinumab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Cytochrome P450 (CYP450) Substrate-Midazolam | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Cytochrome P450 (CYP450) Substrate (Midazolam) |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Midazolam | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC\[0-∞\]) of CYP450 Substrate (Midazolam) |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Warfarin | Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Warfarin) |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Warfarin | Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC\[0-∞\]) of CYP450 Substrate (Warfarin) |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Dextromethorphan | Predose, 1, 2, 4, 6, 8, 10, 24, 48, and 72 hours postdose | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Dextromethorphan) |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Dextromethorphan | Predose, 1, 2, 4, 6, 8, 10, 24, 48, and 72 hours postdose | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC\[0-∞\]) of CYP450 Substrate (Dextromethorphan) |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Omeprazole and its metabolite 5-Hydroxyomeprazole) |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC\[0-∞\]) of CYP450 Substrate (Omeprazole and its metabolite 5-Hydroxyomeprazole) |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Caffeine | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Caffeine) |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 48 Hours (AUC[0-48h]) of CYP450 Substrate-Caffeine | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to 48 hours (AUC\[0-48h\]) of CYP450 Substrate (Caffeine) |
Countries
United States
Participant flow
Pre-assignment details
Multicenter, open-label, 2-period, fixed-sequence study.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Participants received drug cocktail and drug cocktail + Ixekizumab. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Period 2 (Drug Cocktail + Ixekizumab) | Protocol Violation | 1 |
| Period 2 (Drug Cocktail + Ixekizumab) | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 41.8 Years STANDARD_DEVIATION 14.62 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Region of Enrollment United States | 28 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 27 |
| other Total, other adverse events | 1 / 28 | 7 / 27 |
| serious Total, serious adverse events | 0 / 28 | 0 / 27 |
Outcome results
Primary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 48 Hours (AUC[0-48h]) of CYP450 Substrate-Caffeine
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to 48 hours (AUC\[0-48h\]) of CYP450 Substrate (Caffeine)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose
Population: All enrolled participants who received at least 1 dose of study drug with evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 1 mg Midazolam | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 48 Hours (AUC[0-48h]) of CYP450 Substrate-Caffeine | 25000 ng*h/mL | Geometric Coefficient of Variation 48 |
| 160 mg Ixekizumab + 1 mg Midazolam | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 48 Hours (AUC[0-48h]) of CYP450 Substrate-Caffeine | 22400 ng*h/mL | Geometric Coefficient of Variation 57 |
| 80 mg Ixekizumab Q2W (Once Every Two Weeks) + 1 mg Midazolam | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 48 Hours (AUC[0-48h]) of CYP450 Substrate-Caffeine | 22400 ng*h/mL | Geometric Coefficient of Variation 36 |
Primary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Dextromethorphan
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC\[0-∞\]) of CYP450 Substrate (Dextromethorphan)
Time frame: Predose, 1, 2, 4, 6, 8, 10, 24, 48, and 72 hours postdose
Population: All enrolled participants who received at least 1 dose of study drug with evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 1 mg Midazolam | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Dextromethorphan | 11.7 ng*h/mL | Geometric Coefficient of Variation 254 |
| 160 mg Ixekizumab + 1 mg Midazolam | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Dextromethorphan | 12.6 ng*h/mL | Geometric Coefficient of Variation 225 |
| 80 mg Ixekizumab Q2W (Once Every Two Weeks) + 1 mg Midazolam | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Dextromethorphan | 8.53 ng*h/mL | Geometric Coefficient of Variation 273 |
Primary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Midazolam
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC\[0-∞\]) of CYP450 Substrate (Midazolam)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Population: All enrolled participants who received at least 1 dose of study drug with evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 1 mg Midazolam | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Midazolam | 16.6 nanogram*hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 28 |
| 160 mg Ixekizumab + 1 mg Midazolam | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Midazolam | 15.9 nanogram*hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 27 |
| 80 mg Ixekizumab Q2W (Once Every Two Weeks) + 1 mg Midazolam | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Midazolam | 15.4 nanogram*hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 34 |
Primary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC\[0-∞\]) of CYP450 Substrate (Omeprazole and its metabolite 5-Hydroxyomeprazole)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose
Population: All enrolled participants who received at least 1 dose of study drug with evaluable PK data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| 1 mg Midazolam | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole | Omeprazole | 1060 ng*h/mL | Geometric Coefficient of Variation 104 |
| 1 mg Midazolam | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole | 5-Hydroxyomeprazole | 519 ng*h/mL | Geometric Coefficient of Variation 28 |
| 160 mg Ixekizumab + 1 mg Midazolam | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole | Omeprazole | 829 ng*h/mL | Geometric Coefficient of Variation 129 |
| 160 mg Ixekizumab + 1 mg Midazolam | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole | 5-Hydroxyomeprazole | 475 ng*h/mL | Geometric Coefficient of Variation 25 |
| 80 mg Ixekizumab Q2W (Once Every Two Weeks) + 1 mg Midazolam | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole | Omeprazole | 913 ng*h/mL | Geometric Coefficient of Variation 107 |
| 80 mg Ixekizumab Q2W (Once Every Two Weeks) + 1 mg Midazolam | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole | 5-Hydroxyomeprazole | 455 ng*h/mL | Geometric Coefficient of Variation 24 |
Primary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Warfarin
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC\[0-∞\]) of CYP450 Substrate (Warfarin)
Time frame: Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
Population: All enrolled participants who received at least 1 dose of study drug with evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 1 mg Midazolam | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Warfarin | 17600 ng*h/mL | Geometric Coefficient of Variation 29 |
| 160 mg Ixekizumab + 1 mg Midazolam | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Warfarin | 17700 ng*h/mL | Geometric Coefficient of Variation 31 |
| 80 mg Ixekizumab Q2W (Once Every Two Weeks) + 1 mg Midazolam | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Warfarin | 16200 ng*h/mL | Geometric Coefficient of Variation 29 |
Primary
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Caffeine
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Caffeine)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose
Population: All enrolled participants who received at least 1 dose of study drug with evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 1 mg Midazolam | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Caffeine | 2230 ng/mL | Geometric Coefficient of Variation 19 |
| 160 mg Ixekizumab + 1 mg Midazolam | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Caffeine | 2220 ng/mL | Geometric Coefficient of Variation 22 |
| 80 mg Ixekizumab Q2W (Once Every Two Weeks) + 1 mg Midazolam | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Caffeine | 2240 ng/mL | Geometric Coefficient of Variation 22 |
Primary
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Dextromethorphan
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Dextromethorphan)
Time frame: Predose, 1, 2, 4, 6, 8, 10, 24, 48, and 72 hours postdose
Population: All enrolled participants who received at least 1 dose of study drug with evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 1 mg Midazolam | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Dextromethorphan | 0.691 ng/mL | Geometric Coefficient of Variation 291 |
| 160 mg Ixekizumab + 1 mg Midazolam | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Dextromethorphan | 0.878 ng/mL | Geometric Coefficient of Variation 202 |
| 80 mg Ixekizumab Q2W (Once Every Two Weeks) + 1 mg Midazolam | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Dextromethorphan | 0.658 ng/mL | Geometric Coefficient of Variation 285 |
Primary
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Omeprazole and its metabolite 5-Hydroxyomeprazole)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose
Population: All enrolled participants who received at least 1 dose of study drug with evaluable PK data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| 1 mg Midazolam | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole | Omeprazole | 333 ng/mL | Geometric Coefficient of Variation 83 |
| 1 mg Midazolam | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole | 5-Hydroxyomeprazole | 148 ng/mL | Geometric Coefficient of Variation 55 |
| 160 mg Ixekizumab + 1 mg Midazolam | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole | Omeprazole | 340 ng/mL | Geometric Coefficient of Variation 74 |
| 160 mg Ixekizumab + 1 mg Midazolam | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole | 5-Hydroxyomeprazole | 143 ng/mL | Geometric Coefficient of Variation 57 |
| 80 mg Ixekizumab Q2W (Once Every Two Weeks) + 1 mg Midazolam | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole | Omeprazole | 368 ng/mL | Geometric Coefficient of Variation 62 |
| 80 mg Ixekizumab Q2W (Once Every Two Weeks) + 1 mg Midazolam | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole | 5-Hydroxyomeprazole | 137 ng/mL | Geometric Coefficient of Variation 46 |
Primary
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Warfarin
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Warfarin)
Time frame: Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
Population: All enrolled participants who received at least 1 dose of study drug with evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 1 mg Midazolam | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Warfarin | 510 ng/mL | Geometric Coefficient of Variation 26 |
| 160 mg Ixekizumab + 1 mg Midazolam | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Warfarin | 525 ng/mL | Geometric Coefficient of Variation 22 |
| 80 mg Ixekizumab Q2W (Once Every Two Weeks) + 1 mg Midazolam | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Warfarin | 510 ng/mL | Geometric Coefficient of Variation 23 |
Primary
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Cytochrome P450 (CYP450) Substrate-Midazolam
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Cytochrome P450 (CYP450) Substrate (Midazolam)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Population: All enrolled participants who received at least 1 dose of study drug with evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 1 mg Midazolam | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Cytochrome P450 (CYP450) Substrate-Midazolam | 4.56 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 24 |
| 160 mg Ixekizumab + 1 mg Midazolam | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Cytochrome P450 (CYP450) Substrate-Midazolam | 4.92 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 24 |
| 80 mg Ixekizumab Q2W (Once Every Two Weeks) + 1 mg Midazolam | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Cytochrome P450 (CYP450) Substrate-Midazolam | 4.83 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 26 |