Phase 1
Completed N=31
Brodalumab Drug-Drug Interaction (DDI) and Intensive Pharmacodynamic (PK) Study in Psoriasis Subjects
Source: ClinicalTrials.gov NCT01937260 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: The Maximum Observed Concentration of Midazolam After a Single Dose of Brodalumab — 11.5 nanograms per milliliter
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Maximum Observed Concentration of Midazolam After a Single Dose of Brodalumab |
11.5 | — |
| PRIMARY The Area Under Drug Concentration Time Curve From Zero to Infinity (AUCinf) |
41.5 | — |
| PRIMARY The Area Under the Drug-concentration Curve of Midazolam After a Single Dose of Brodalumab From Zero Tot he Last Time of Quantifiable Concentration |
39 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has had stable moderate to severe plaque psoriasis for at least 6 months
- body mass index (BMI) between ≥ 18.0 and ≤ 38.0 kg/m2
- body weight between ≥ 50 and ≤ 130 kg
- no known history of active tuberculosis
Exclusion Criteria
- Female subjects who are lactating/breastfeeding
- History or evidence of clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
Data sourced from ClinicalTrials.gov (NCT01937260). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.