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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
28
Administered orally
Administered SC
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Avail Clinical Research LLC
DeLand, Florida, United States
High Point Clinical Trials Center
High Point, North Carolina, United States
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
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
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
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
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
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Predose, 1, 2, 4, 6, 8, 10, 24, 48, and 72 hours postdose
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
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
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
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