NCT03358706

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

A Phase 1, Open-label, Drug Interaction 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.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2018-02-02
• Primary completion: 2021-11-22
• Completion: 2021-11-22
• First posted: 2017-12-02
• Last updated: 2025-08-21

Locations

16 sites across 4 countries: United States, Belgium, Germany, United Kingdom

Regulatory

• FDA-regulated drug study