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NCT02397382 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study to Evaluate the Effect of a Single Dose of Guselkumab (CNTO 1959) on CYP 450 Enzyme Activities After Subcutaneous Administration in Participants With Psoriasis
A Phase 1 study of Psoriasis, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 8
- Study locations
NCT02397382: Completed Phase 1 study of Psoriasis, sponsored by Janssen Research & Development.
NCT02397382 is a Phase 1 study of Psoriasis that has completed, run by Janssen Research & Development. The registered enrollment target is 16 participants, below the 489-participant average among 125 other Psoriasis trials with a reported enrollment target (97% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02397382, a Phase 1 study of Psoriasis, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 8
- Study locations
Study Summary
The purpose of this study is to evaluate the potential effects of a single dose of 200 milligram (mg) guselkumab on the plasma concentrations of a cocktail of representative probe substrates of Cytochrome P450 isozymes (CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP1A2) in participants with moderate to severe psoriasis.
Primary Outcome
The Cmax is the maximum observed plasma concentration of Midazolam, Omeprazole, Dextromethorphan, Caffeine and S-warfarin.
Conditions Studied
Interventions
- DRUG Guselkumab
- DRUG Midazolam
- DRUG Omeprazole
- DRUG Warfarin
- DRUG Dextromethorphan
Study Locations (8)
Pennsylvania
- - Duncansville
- - Pittsburgh
Alabama
- - Anniston
California
- - North Hollywood
Florida
- - Orlando
Georgia
- - Atlanta
North Carolina
- - High Point
Texas
- - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2015-06-18 |
| Est. Completion | 2016-08-31 |
| Phase | Phase 1 |
What the finished NCT02397382 record still lists
NCT02397382 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 489-participant average among 125 other Psoriasis trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Psoriasis appearing as the primary indexed condition, and to 5 interventions - of which Guselkumab is the first listed.
NCT02397382 lists 8 locations in 7 states (Pennsylvania, Alabama, California).
Frequently Asked Questions
What is clinical trial NCT02397382 about?
NCT02397382 is a clinical study titled "Pharmacokinetic Study to Evaluate the Effect of a Single Dose of Guselkumab (CNTO 1959) on CYP 450 Enzyme Activities After Subcutaneous Administration in Participants With Psoriasis". The purpose of this study is to evaluate the potential effects of a single dose of 200 milligram (mg) guselkumab on the plasma concentrations of a cocktail of representative probe substrates of Cytochrome P450 isozymes (CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP1A2) in participants with moderate to se...
What is the current status of trial NCT02397382?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2015-06-18. Estimated completion is 2016-08-31.
What conditions does trial NCT02397382 study?
This clinical trial studies the following conditions: Psoriasis.
What interventions are being tested in trial NCT02397382?
The interventions under investigation include: Guselkumab (DRUG), Midazolam (DRUG), Omeprazole (DRUG), Warfarin (DRUG), Dextromethorphan (DRUG).
Who is sponsoring clinical trial NCT02397382?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02397382 being conducted?
This trial has 8 study locations across Alabama, California, Florida, Georgia, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Psoriasis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02397382's enrollment target sits among peer trials
16 115th of 125 higher than 9 of 125 other Psoriasis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Psoriasis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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