Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Ixekizumab in Participants With Plaque Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02993471
Recruitment Status : Completed
First Posted : December 15, 2016
Results First Posted : March 12, 2019
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Drug Cocktail Drug: Ixekizumab Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of the Effect of Ixekizumab on the Pharmacokinetics of Cytochrome P450 Substrates in Patients With Moderate-to-Severe Plaque Psoriasis
Actual Study Start Date : December 22, 2016
Actual Primary Completion Date : November 21, 2017
Actual Study Completion Date : November 21, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ixekizumab

Arm Intervention/treatment
Experimental: Drug Cocktail
Drug cocktail (caffeine, warfarin [plus vitamin K], omeprazole, dextromethorphan, and midazolam) administered orally once in Period 1 (day 1).
Drug: Drug Cocktail
Administered orally
Other Name: Caffeine + Warfarin (plus vitamin K) + Omeprazole + Dextromethorphan + Midazolam

Experimental: Drug Cocktail + Ixekizumab
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
Administered orally
Other Name: Caffeine + Warfarin (plus vitamin K) + Omeprazole + Dextromethorphan + Midazolam

Drug: Ixekizumab
Administered SC
Other Name: LY2439821




Primary Outcome Measures :
  1. 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): Maximum Observed Drug Concentration (Cmax) of Cytochrome P450 (CYP450) Substrate (Midazolam)

  2. 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): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of CYP450 Substrate (Midazolam)

  3. 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): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Warfarin)

  4. 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): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of CYP450 Substrate (Warfarin)

  5. 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): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Dextromethorphan)

  6. 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 ]
    Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of CYP450 Substrate (Dextromethorphan)

  7. 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): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Omeprazole and its metabolite 5-Hydroxyomeprazole)

  8. 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): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of CYP450 Substrate (Omeprazole and its metabolite 5-Hydroxyomeprazole)

  9. 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): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Caffeine)

  10. 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 ]
    Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to 48 hours (AUC[0-48h]) of CYP450 Substrate (Caffeine)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993471


Locations
Layout table for location information
United States, California
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801
United States, Florida
Avail Clinical Research LLC
DeLand, Florida, United States, 32720
United States, North Carolina
High Point Clinical Trials Center
High Point, North Carolina, United States, 27265
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Layout table for investigator information
Study Director: 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 Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] December 8, 2016
Statistical Analysis Plan  [PDF] May 31, 2017


Additional Information:
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02993471     History of Changes
Other Study ID Numbers: 16126
I1F-MC-RHBU ( Other Identifier: Eli Lilly and Company )
First Posted: December 15, 2016    Key Record Dates
Results First Posted: March 12, 2019
Last Update Posted: March 12, 2019
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Vitamins
Vitamin K
Midazolam
Caffeine
Dextromethorphan
Warfarin
Omeprazole
Ixekizumab
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Central Nervous System Stimulants