Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years - 75 Years|
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.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Janssen Research & Development, LLC|
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|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Belgium, Germany, Sweden, United Kingdom, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Study Website:||View Trial Website|
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.
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.