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NCT01937260 · ClinicalTrials.gov registry record · Phase 1
Brodalumab Drug-Drug Interaction (DDI) and Intensive Pharmacodynamic (PK) Study in Psoriasis Subjects
A Phase 1 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT01937260: Completed Phase 1 study, sponsored by Bausch Health Americas.
NCT01937260 is a Phase 1 study that has completed, run by Bausch Health Americas. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01937260, a Phase 1 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
This is a phase 1, multi-center, open-label, drug-drug interaction (DDI) and PK study in subjects with moderate to severe plaque psoriasis. It is designed to evaluate the effect of brodalumab on midazolam PK in addition to assessing single dose PK of brodalumab in subjects with moderate to severe plaque psoriasis.
Primary Outcome
Midazolam pharmacokinetic parameter estimates after single oral dose of Midazolam 2 mg on Day 1 and Day 9 and a single administration of Brodalumab 210 mg on Day 2 with PK sampling collected on Day 30
Interventions
- DRUG Brodalumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2013-09 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
What the finished NCT01937260 record still lists
NCT01937260 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 1 intervention - of which Brodalumab is the first listed.
NCT01937260 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01937260 about?
NCT01937260 is a clinical study titled "Brodalumab Drug-Drug Interaction (DDI) and Intensive Pharmacodynamic (PK) Study in Psoriasis Subjects". This is a phase 1, multi-center, open-label, drug-drug interaction (DDI) and PK study in subjects with moderate to severe plaque psoriasis. It is designed to evaluate the effect of brodalumab on midazolam PK in addition to assessing single dose PK of brodalumab in subjects with moderate to severe pl...
What is the current status of trial NCT01937260?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2013-09. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01937260?
The interventions under investigation include: Brodalumab (DRUG).
Who is sponsoring clinical trial NCT01937260?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01937260's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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