Study Complete
Sponsor ID
20110184
Brodalumab Drug-Drug Interaction (DDI) and Intensive Pharmacodynamic (PK) Study in Psoriasis Subjects
Study Details
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.
Protocol Summary
Primary Outcome Measures
The maximum observed concentration of midazolam after a single dose of brodalumab
Timeframe: up to 22 days to 30 days
The time to maximum concentration of midazolam after a single dose of brodalumab
Timeframe: up to 22 days to 30 days
The area under the serum-concentration curve of midazolam after a single dose of brodalumab
Timeframe: up to 22 days to 30 days
Secondary Outcome Measures
The number of treatment emergent adverse events per subject, including changes in vital signs, ECG, physical examinations, and laboratory safety parameters
Timeframe: up to 22 to 30 days
The number of subjects with anti-brodalumab antibodies after a single dose of brodalumab
Timeframe: up to 22 to 30 days
Study Documents
Study Synopsis
Available Language(s): English
Locations
Location
Research Site
Austin, TX, United States, 78759
Status
Completed
Location
Research Site
Christchurch, New Zealand, 8011
Status
Recruiting
Location
Research Site
Dallas, TX, United States, 75231
Status
Recruiting
Location
Research Site
Adelaide, SA, Australia, 5000
Status
Recruiting
Location
Research Site
Anaheim, CA, United States, 92801
Status
Recruiting
Location
Research Site
Grafton, Auckland, New Zealand, 1010
Status
Recruiting
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