Trial intelligence / Profile preview

Ustekinumab CYP Interaction Study in CD/UC

NCT03358706Phase 1Terminated

Sponsor
Janssen Pharmaceutical
Start
Feb 2018
Primary completion
Nov 2021
Modality
Monoclonal Antibodies
Countries
4
01

Overview

Phase 1, open-label trial of ustekinumab in Crohn's disease and ulcerative colitis (UC) (2 arms), sponsored by Janssen Pharmaceutical. Primary endpoints: Geometric Mean Ratio (Day 22/ Day 1) of the Maximum Plasma Concentration (Cmax) of Cytochrome P450 Probe Substrates, Geometric Mean Ratio (Day 113/ Day 1) of the Maximum Plasma Concentration (Cmax) of Cytochrome P450 Probe Substrates and 2 more. Started Feb 2018; status: terminated.

02

Drugs

ustekinumab
03

Conditions

Crohn's diseaseulcerative colitis (UC)

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