A Study of Ixekizumab in Participants With Plaque Psoriasis

NCT02993471 | Completed Phase 1 Results

• 2 other identifiers: 16126I1F-MC-RHBU
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (10)

• 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

• 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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose

Study Arms (2)

Drug Cocktail

EXPERIMENTAL

Drug cocktail (caffeine, warfarin \[plus vitamin K\], omeprazole, dextromethorphan, and midazolam) administered orally once in Period 1 (day 1).

Drug: Drug Cocktail

Drug Cocktail + Ixekizumab

EXPERIMENTAL

Drug cocktail (caffeine, warfarin \[plus vitamin K\], omeprazole, dextromethorphan, and midazolam) administered orally twice in Period 2 (day 8 and day 85). Ixekizumab administered subcutaneously (SC) on multiple occasions in Period 2.

Drug: Drug Cocktail; Drug: Ixekizumab

Interventions

Drug Cocktail DRUG

Administered orally

Also known as: Caffeine + Warfarin (plus vitamin K) + Omeprazole + Dextromethorphan + Midazolam

Drug Cocktail; Drug Cocktail + Ixekizumab

Ixekizumab DRUG

Administered SC

Also known as: LY2439821

Drug Cocktail + Ixekizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Avail Clinical Research LLC

DeLand, Florida, 32720, United States

Location

High Point Clinical Trials Center

High Point, North Carolina, 27265, United States

Location

Related Links

• Click here for more information about this study: A Study of Ixekizumab in Participants with Plaque Psoriasis

MeSH Terms

Conditions

Psoriasis

Interventions

Caffeine; Warfarin; Omeprazole; Dextromethorphan; Midazolam; ixekizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Benzimidazoles; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Benzodiazepines; Benzazepines

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 15, 2016
• Study Start: December 22, 2016
• Primary Completion: November 21, 2017
• Study Completion: November 21, 2017
• Last Updated: March 12, 2019
• Results First Posted: March 12, 2019

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)