A Phase 1 Study for patients with Moderate to Severe Crohn’s Diseas
Research type
Research Study
Full title
A Phase 1, Open-label, Drug Interaction 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
IRAS ID
239919
Contact name
Paul Knight
Contact email
Sponsor organisation
Janssen Reserarch and Development
Eudract number
2017-000831-16
Duration of Study in the UK
3 years, 5 months, 9 days
Research summary
This is an open label phase 1 study being conducted in crohn's disease (CD) patients and healthy volunteers (HV). The trial is designed to examine the effect of ustekinumab (intravenous and sub-cutaneous doses) on the absorption, distribution, metabolism, and excretion(pharmacokinetics or PK) of some commonly available prescription drugs (via a 'probe cocktail')in CD patients. The drugs chosen represent different classes of CYP substrates considered important in understanding drug metabolism. The HV will be only administered with the probe cocktail. Comparison of any differences in PK of the probe cocktail between the CD and HV will be performed to facilitate understanding of disease effects on drug metabolism. Due to the nature of the disease population, method of drug delivery, the requirement for overnight inpatient stays and intensive PK sampling, the sponsor will ensure that the trial be conducted in specialist phase 1 facilities with specialist (GI) clinicians available through out the dosing and treatment period.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
18/NW/0313
Date of REC Opinion
2 Jul 2018
REC opinion
Further Information Favourable Opinion