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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

NCT03058419 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-06-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-14
Primary Completion
2017-05-15
Completion
2017-05-15

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03058419 on ClinicalTrials.gov