NCT02397382View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

June 18, 2015

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2016

Conditions
Psoriasis
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.

Trial Locations (8)

Unknown

Anniston

North Hollywood

Orlando

Atlanta

High Point

Duncansville

Pittsburgh

San Antonio

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02397382 - 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 | Biotech Hunter | Biotech Hunter