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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria For Crohn's Disease (CD) Participants

  • - Participant must have a body weight in the range of 45 to 110 kilogram (kg) inclusive and have a body mass index (BMI) of 18 to 35 kilogram per meter square (kg/m^2) inclusive - Have moderate to severe CD or fistulizing CD of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by histology, and/or endoscopy For Healthy Volunteers - Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening - Healthy on the basis of clinical laboratory tests performed at screening and Day-1 - If a woman of childbearing potential, she must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening; and a negative urine pregnancy test at Day -1 Exclusion Criteria For CD Participants - Has complications of CD such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery in the next 3 months, could preclude the use of the Crohn's Disease Activity Index (CDAI) to assess response to therapy, would possibly confound the ability to assess the effect of treatment with ustekinumab, or would alter the absorption of the probe cocktail - Currently has or is suspected to have an abscess.
Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks prior to baseline, or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery. Participants with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses identified For Healthy Volunteers Participants - Has an abnormal C-reactive protein (CRP) greater than (>) 2* upper limit of normal (ULN) - Has had major surgery (example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is in screening or is expected to participate in the study (5 weeks) - Is pregnant, nursing, or planning a pregnancy (both men and women) during the study

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03358706
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen Research & Development, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation Janssen Research & Development, LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, Germany, Sweden, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Crohn's Disease Participants: Ustekinumab + Probe Cocktail

Participants will receive a single Intravenous (IV) infusion dose of ustekinumab (dosage to be decided based on body weight) on Day 8 and a ustekinumab 90 milligram (mg) maintenance dose via subcutaneous (SC) route on Day 64. A second optional maintenance dose may be administered on Day 120 based on participants clinical response assessed by investigator. The probe cocktail (2 milligram [mg] of midazolam, 10 mg of warfarin plus 10 mg of vitamin K, 20 mg of omeprazole, 30 mg dextromethorphan, and 100 mg of caffeine) will be administered orally on Days 1, 22, and 113.

Experimental: Healthy Participants: Probe Cocktail

Participants will receive the probe cocktail (2 mg of midazolam, 10 mg of warfarin plus 10 mg of vitamin K, 20 mg of omeprazole, 30 mg dextromethorphan, and 100 mg of caffeine) orally on Day 1.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

WCCT Global, LLC, Cypress, California

Status

Completed

Address

WCCT Global, LLC

Cypress, California, 90630

Accel Research Sites, DeLand, Florida

Status

Withdrawn

Address

Accel Research Sites

DeLand, Florida, 32720

Ocean Blue Medical Research Center Inc., Miami Springs, Florida

Status

Completed

Address

Ocean Blue Medical Research Center Inc.

Miami Springs, Florida, 33166

Advanced Pharma CR, LLC, Miami, Florida

Status

Withdrawn

Address

Advanced Pharma CR, LLC

Miami, Florida, 33147

University Of Minnesota, Minneapolis, Minnesota

Status

Withdrawn

Address

University Of Minnesota

Minneapolis, Minnesota, 55455

Duke University, Durham, North Carolina

Status

Recruiting

Address

Duke University

Durham, North Carolina, 27710

University of Washington, Seattle, Washington

Status

Not yet recruiting

Address

University of Washington

Seattle, Washington, 98195

International Sites

Ghent University Hospital, Gent, Belgium

Status

Recruiting

Address

Ghent University Hospital

Gent, , 9000

Liege, Belgium

Status

Recruiting

Address

Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

Liege, , 4000

Az Sint-Maarten, Mechelen, Belgium

Status

Recruiting

Address

Az Sint-Maarten

Mechelen, , 2800

Clinical Pharmacology Unit, Merksem, Belgium

Status

Recruiting

Address

Clinical Pharmacology Unit

Merksem, , 2170

Universitatsklinikum Bonn, Bonn, Germany

Status

Recruiting

Address

Universitatsklinikum Bonn

Bonn, , 53127

Universitatsklinikum Essen, Essen, Germany

Status

Terminated

Address

Universitatsklinikum Essen

Essen, , 45147

Universitatsklinikum Freiburg, Freiburg, Germany

Status

Completed

Address

Universitatsklinikum Freiburg

Freiburg, , 79106

Hamburg, Germany

Status

Recruiting

Address

CTC North GmbH & Co. KG, Am Universitätsklinikum Hamburg-Eppendorf

Hamburg, , 20251

Clinical Research Center Hannover, Hannover, Germany

Status

Recruiting

Address

Clinical Research Center Hannover

Hannover, , 30625

University Hospital Heidelberg, Heidelberg, Germany

Status

Recruiting

Address

University Hospital Heidelberg

Heidelberg, , 69120

Danderyd Hospital, Stockholm, Sweden

Status

Recruiting

Address

Danderyd Hospital

Stockholm, , 18288

Wythenshawe Hospital, Greater Manchester, United Kingdom

Status

Recruiting

Address

Wythenshawe Hospital

Greater Manchester, , M23 9LT

Royal Liverpool University Hospital, Liverpool, United Kingdom

Status

Recruiting

Address

Royal Liverpool University Hospital

Liverpool, , L7 8XP

Guy's Hospital, London, United Kingdom

Status

Recruiting

Address

Guy's Hospital

London, , SE1 9RT

Southampton, United Kingdom

Status

Not yet recruiting

Address

Southampton University Hospitals NHS Trust

Southampton, , SO16 6YD

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