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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

NCT02397382 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-09-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Guselkumab

Guselkumab will be administered as a single dose of 200 milligram (mg) by subcutaneous injection (2\*100 mg) on Day 8.

DRUG

Midazolam

Midazolam will be administered orally as probe cocktail containing 0.03 mg per kilogram (kg) once on Day 1, 15 and 36.

DRUG

Warfarin

Warfarin will be administered orally as probe cocktail containing 10 mg once on Day 1, 15 and 36.

DRUG

Omeprazole

Omeprazole will be administered orally as probe cocktail containing 20 mg once on Day 1, 15 and 36.

DRUG

Dextromethorphan

Dextromethorphan will be administered orally as probe cocktail containing 30 mg once on Day 1, 15 and 36.

DRUG

Caffeine

Caffeine will be administered orally as probe cocktail containing 100 mg once on Day 1, 15 and 36.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-18
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02397382 on ClinicalTrials.gov