Brodalumab Drug-Drug Interaction (DDI) and Intensive Pharmacodynamic (PK) Study in Psoriasis Subjects

Status:	Completed
Conditions:	Psoriasis
Therapuetic Areas:	Dermatology / Plastic Surgery
Healthy:	No
Age Range:	18 - 75
Updated:	5/5/2014
Start Date:	September 2013
End Date:	June 2014
Contact:	Amgen Call Center
Phone:	866-572-6436

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

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.

Approximately 30 subjects will be enrolled into two groups. Group 1 consists of 20 subjects
and will receive 2 oral doses of midazolam and a single subcutaneous (SC) dose of
brodalumab. Group 2 consists of 10 subjects and will receive a single SC dose of
brodalumab.

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.

We found this trial at

sites

Clinical Trial Facility in Irvine California

Irvine, California 92697

from

Irvine, CA