NCT03058419

A Study to Evaluate the Effect of Oral Doses of JNJ-54175446 on the Inhibition of Cytochrome P450 CYP3A4, CYP2C9, CYP1A2 and CYP2D6 Activity and the Induction of CYP2B6 and CYP2C19 Activity Using a Multiple Probe Substrate Cocktail in Healthy Subjects

An Open-label Drug Interaction Study in Healthy Subjects to Evaluate the Effect of Oral Doses of JNJ-54175446 on the Inhibition of Cytochrome P450 CYP3A4, CYP2C9, CYP1A2 and CYP2D6 Activity and the Induction of CYP2B6 and CYP2C19 Activity Using a Multiple Probe Substrate Cocktail

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this study is to determine the potential inhibitory/inducing effects of JNJ-54175446 after single and repeated dosing on the single-dose pharmacokinetics (PK) of a cocktail, containing selective probes of cytochrome P450 (CYP) enzymes (CYP3A4/A5, CYP2C9, CYP1A2, CYP2D6, CYP2B6, and CYP2C19) in healthy adult subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JNJ-54175446 150 mg	Subjects will receive JNJ-54175446 150 mg capsules orally (1\*100 mg + 1\*50 mg) under fasted conditions on Day 7, 9, 10 and 11.
DRUG	JNJ-54175446 600 mg	Subjects will receive JNJ-54175446 600 mg (6\*100 mg capsules) orally on Day 8.
DRUG	Midazolam 2 mg	Subjects will receive midazolam 2 mg oral emulsion \[2 (milligram per milliliter (mg/mL)\] as a drug cocktail on Day 1, 7 and 11.
DRUG	Warfarin 10 mg	Subjects will receive warfarin 10 mg tablets (2\*5 mg) orally as a drug cocktail on Day 1, 7 and 11.
DRUG	Caffeine 50 mg	Subjects will receive caffeine 50 mg tablet (1\*50 mg) orally as a drug cocktail on Day 1, 7 and 11.
DRUG	Dextromethorphan 30 mg	Subjects will receive dextromethorphan 30 mg capsule (1\*30 mg) orally as a drug cocktail on Day 1, 7 and 11.
DRUG	Bupropion 150 mg	Subjects will receive Bupropion 150 mg tablet (1\*150 mg) orally as a drug cocktail on Day 1, 7 and 11.
DRUG	Omeprazole 20 mg	Subjects will receive omeprazole 20 mg capsule (1\*20 mg) orally as a drug cocktail on Day 1, 7 and 11.

Timeline

• Start date: 2017-03-14
• Primary completion: 2017-05-15
• Completion: 2017-05-15
• First posted: 2017-02-20
• Last updated: 2017-06-08

Locations

1 site across 1 country: Belgium