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

Completed · Phase 1

Conditions studied: Psoriasis

In brief

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.

Key facts

Study ID

NCT01937260

Run by

Bausch Health Americas, Inc.

People needed

31

Starts

2013-09-01

Expected to finish

2014-12-01

Last updated by the study team

2017-04-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Research Site — Anaheim, California, United States
• Research Site — Irvine, California, United States
• Research Site — Ocala, Florida, United States
• Research Site — Austin, Texas, United States
• Research Site — Dallas, Texas, United States
• Research Site — Herston, Queensland, Australia
• Research Site — Adelaide, South Australia, Australia
• Research Site — Prahran, Victoria, Australia
• Research Site — Christchurch, New Zealand
• Research Site — Grafton, Auckland, New Zealand

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.