At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 31 enrolled
Drug / intervention
Brodalumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label Study to Evaluate the Effect of Brodalumab on the Pharmacokinetics of Midazolam and Assess Single-Dose Brodalumab Pharmacokinetics in Subjects With Moderate to Severe Plaque Psoriasis
In Brief
A Phase 1 clinical trial evaluating Brodalumab for Psoriasis. Completed, enrolled 31 participants across 10 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
CountriesAustralia, New Zealand, United States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartSep 2013
First PostedSep 2013
Primary CompletionJul 2014
Study CompletionDec 2014
TodayJul 2026
First PostedSep 9, 2013
Enrollment StartSep 1, 2013
Primary CompletionJul 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 12.8 years ago
Interventions
Brodalumabdrug
Group 1 consists of 20 subjects and will receive 2 oral doses of midazolam and a single SC dose of brodalumab. Group 2 consists of 10 subjects and will receive a single SC dose of brodalumab.