Clinical Trial

Treating and Dosing of Moderate to Severe Crohn's Disease

Study Description

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

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 moderate to severe Crohn's disease (CD).

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

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.

Additional Information

Official Study Title

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 Moderate to Severe Crohn's Disease.

Clinical Trial ID

NCT03358706

ParticipAid ID

7e55Ze