Trial Details
TERMINATEDBasic Information
| Clinical ID | c1337 |
|---|---|
| Identifier | NCT03358706 |
| Trial Title | 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 |
| Trial URL | Visit Original Page |
Study Information
| Study Results | NO |
|---|---|
| Conditions | Crohn Disease|Ulcerative Colitis |
| Interventions | DRUG: Ustekinumab IV Infusion|DRUG: Ustekinumab SC Injection|DRUG: Midazolam 2 mg|DRUG: Warfarin 10 mg|DRUG: Vitamin K 10 mg|DRUG: Omeprazole 20 mg|DRUG: Dextromethorphan 30 mg|DRUG: Caffeine 100 mg |
Participant Information
| Sponsor | Janssen Research & Development, LLC |
|---|---|
| City | Cypress |
| Country/Region | United States |
Enrollment Criteria
| Sex Requirement | ALL |
|---|---|
| Age Requirement | ADULT, OLDER_ADULT |
Study Design
| Study Type | INTERVENTIONAL |
|---|---|
| Phase | PHASE1 |
Time Information
| Start Date | 2018-02-02 |
|---|---|
| Primary Completion Date | 2021-11-22 |
| Completion Date | 2021-11-22 |