Pharmacokinetic Study to Evaluate the Effect of a Single Dose of Guselkumab (CNTO 1959) on CYP 450 Enzyme Activities After Subcutaneous Administration in Participants With Psoriasis

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02397382
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab — DRUG
    Guselkumab will be administered as a single dose of 200 milligram (mg) by subcutaneous injection (2\*100 mg) on Day 8.
  • Midazolam — DRUG
    Midazolam will be administered orally as probe cocktail containing 0.03 mg per kilogram (kg) once on Day 1, 15 and 36.
  • Warfarin — DRUG
    Warfarin will be administered orally as probe cocktail containing 10 mg once on Day 1, 15 and 36.
  • Omeprazole — DRUG
    Omeprazole will be administered orally as probe cocktail containing 20 mg once on Day 1, 15 and 36.
  • Dextromethorphan — DRUG
    Dextromethorphan will be administered orally as probe cocktail containing 30 mg once on Day 1, 15 and 36.
  • Caffeine — DRUG
    Caffeine will be administered orally as probe cocktail containing 100 mg once on Day 1, 15 and 36.

Study Details

The purpose of this study is to evaluate the potential effects of a single dose of 200 milligram (mg) guselkumab on the plasma concentrations of a cocktail of representative probe substrates of Cytochrome P450 isozymes (CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP1A2) in participants with moderate to severe psoriasis.

Key Dates

Start date
Jun 18, 2015
Status verified
Sep 2017
Primary completion
Aug 31, 2016
Completion
Aug 31, 2016

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Guselkumab and Cytochrome P450 Probe Cocktail
    Participants will be administered single dose of Guselkumab 200 milligram (mg) by subcutaneous injection (2\*100 mg) on Day 8 and Cytochrome P450 probe cocktail consist of midazolam, warfarin/vitamin K, omeprazole, dextromethorphan and caffeine orally once on Day 1,15 and 36.

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Screening up to 96 hours on Day 1, 15 and 36 ]

Locations (8)

FacilityCityStateZIPSite coordinators
-AnnistonAlabama--
-North HollywoodCalifornia--
-OrlandoFlorida--
-AtlantaGeorgia--
-High PointNorth Carolina--
-DuncansvillePennsylvania--
-PittsburghPennsylvania--
-San AntonioTexas--

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By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease

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