A Study of Ixekizumab in Participants With Plaque Psoriasis

Part of paid clinical trials in Anaheim, California.

Sponsor
Eli Lilly and Company
Study ID
NCT02993471
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Drug Cocktail — DRUG
    Administered orally
  • Ixekizumab — DRUG
    Administered SC

Study Details

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.

Key Dates

Start date
Dec 22, 2016
Status verified
Dec 2017
Primary completion
Nov 21, 2017
Completion
Nov 21, 2017

Study Design

Enrollment
28 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

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

Primary Outcome Measure

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 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Anaheim Clinical Trials, LLCAnaheimCalifornia92801-
Avail Clinical Research LLCDeLandFlorida32720-
High Point Clinical Trials CenterHigh PointNorth Carolina27265-

Find similar trials in Anaheim, CA

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Anaheim Clinical Trials, LLC· Anaheim, CAAvail Clinical Research LLC· DeLand, FLHigh Point Clinical Trials Center· High Point, NC

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