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NCT03358706 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by Janssen Research & Development.
- Terminated
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT03358706 is a Phase 1 study that was terminated before completion, run by Janssen Research & Development. The registered enrollment target is 28 participants.
The verdict
NCT03358706, a Phase 1 study, was terminated before completion, sponsored by Janssen Research & Development.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study 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 cocktail of representative probe substrates of cytochrome P450 (CYP) enzymes (CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP1A2) in participants with Active Crohn's disease (CD) or Ulcerative Colitis (UC).
Interventions
- DRUG Midazolam 2 mg
- DRUG Ustekinumab IV Infusion
- DRUG Ustekinumab SC Injection
- DRUG Warfarin 10 mg
- DRUG Vitamin K 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2018-02-02 |
| Est. Completion | 2021-11-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03358706
The ClinicalTrials.gov registry entry for NCT03358706 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Midazolam 2 mg is the first listed.
NCT03358706 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03358706 about?
NCT03358706 is a clinical study titled "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". 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 cocktail of representative probe substrates of cytochrome P450 (CYP) enzymes (CYP3A4, CYP2C9, CYP2C19, CYP2...
What is the current status of trial NCT03358706?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2018-02-02. Estimated completion is 2021-11-22.
What interventions are being tested in trial NCT03358706?
The interventions under investigation include: Midazolam 2 mg (DRUG), Ustekinumab IV Infusion (DRUG), Ustekinumab SC Injection (DRUG), Warfarin 10 mg (DRUG), Vitamin K 10 mg (DRUG).
Who is sponsoring clinical trial NCT03358706?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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