A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis

Summary

The purpose of this study is to evaluate the potential effects of an intravenous (IV) induction and subcutaneous (SC) maintenance administration of ustekinumab on the pharmacokinetic (PK) of a cocktail of representative probe substrates of cytochrome P450 (CYP) enzymes (CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP1A2) in participants with Active Crohn's disease (CD) or Ulcerative Colitis (UC).

Conditions

• Crohn Disease
• Ulcerative Colitis

Interventions

DRUG

Ustekinumab IV Infusion

Participants will receive a single IV infusion dose of ustekinumab (dosage to be decided based on body weight) on Day 8.

DRUG

Ustekinumab SC Injection

Participants will receive a Ustekinumab 90 mg SC maintenance dose on Day 64. A second optional maintenance dose may be administered on Day 120 based on participants clinical response assessed by investigator.

DRUG

Midazolam 2 mg

Participants will receive 2 milligram per milliliter (mg/ml) syrup of midazolam as a component of the Cytochrome P 450 probe cocktail orally.

DRUG

Warfarin 10 mg

Participants will receive 10 mg tablet of warfarin as a component of the Cytochrome P 450 probe cocktail orally.

DRUG

Vitamin K 10 mg

Participants will receive 10 mg tablet of vitamin K as a component of the Cytochrome P 450 probe cocktail orally.

DRUG

Omeprazole 20 mg

Participants will receive 20 mg capsule of omeprazole as a component of the Cytochrome P 450 probe cocktail orally.

DRUG

Dextromethorphan 30 mg

Participants will receive 30 mg capsule of dextromethorphan as a component of the Cytochrome P 450 probe cocktail orally.

DRUG

Caffeine 100 mg

Participants will receive 100 mg tablet of caffeine as a component of the Cytochrome P 450 probe cocktail orally.

Sponsors & Collaborators

• Janssen Research & Development, LLC

  lead INDUSTRY

Principal Investigators

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

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-02-02

Primary Completion

2021-11-22

Completion

2021-11-22

FDA Drug

Yes

Countries

• United States
• Belgium
• Germany
• United Kingdom

Study Locations