Status:
TERMINATED
A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Crohn Disease
Ulcerative Colitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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 cocktai...
Eligibility Criteria
Inclusion
- 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 had 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
Exclusion
Key Trial Info
Start Date :
February 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2021
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03358706
Start Date
February 2 2018
End Date
November 22 2021
Last Update
August 21 2025
Active Locations (16)
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1
WCCT Global, LLC
Cypress, California, United States, 90630
2
Ocean Blue Medical Research Center Inc.
Miami Springs, Florida, United States, 33166
3
Duke University
Durham, North Carolina, United States, 27710
4
Ghent University Hospital
Ghent, Belgium, 9000