A Study of Ixekizumab in Participants With Plaque Psoriasis

Psoriasis Clinical Trial

Official title:

Evaluation of the Effect of Ixekizumab on the Pharmacokinetics of Cytochrome P450 Substrates in Patients With Moderate-to-Severe Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02993471
• Other study ID #: 16126
• Secondary ID: I1F-MC-RHBU
• Status: Completed
• Phase: Phase 1
• Start date: December 22, 2016
• Est. completion date: November 21, 2017

Study information

• Verified date: December 2017
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 21, 2017
• Est. primary completion date: November 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Drug Cocktail
Administered orally
• Ixekizumab
Administered SC

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Primary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of CYP450 Substrate-Midazolam	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-8]) of CYP450 Substrate (Midazolam)	Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Primary	Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Warfarin	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
Primary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of CYP450 Substrate-Warfarin	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-8]) of CYP450 Substrate (Warfarin)	Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
Primary	Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Dextromethorphan	Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Dextromethorphan)	Predose, 1, 2, 4, 6, 8, 10, 24, 48, and 72 hours postdose
Primary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of CYP450 Substrate-Dextromethorphan	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-8]) of CYP450 Substrate (Dextromethorphan)	Predose, 1, 2, 4, 6, 8, 10, 24, 48, and 72 hours postdose
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)	Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose
Primary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-8]) of CYP450 Substrate (Omeprazole and its metabolite 5-Hydroxyomeprazole)	Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose
Primary	Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Caffeine	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
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)	Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose

External Links

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