Clinical trial NCT01937260: Brodalumab Drug-Drug Interaction (DDI) and Intensive Pharmacodynamic (PK) Study in Psoriasis Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2013-09-09
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: 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.

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.

Primary outcomes:
measure: The Maximum Observed Concentration of Midazolam After a Single Dose of Brodalumab
timeFrame: Day 1 to day 9
measure: The Area Under Drug Concentration Time Curve From Zero to Infinity (AUCinf)
timeFrame: Day 1 to Day 9
measure: The Area Under the Drug-concentration Curve of Midazolam After a Single Dose of Brodalumab From Zero Tot he Last Time of Quantifiable Concentration
timeFrame: Day 1 to Day 9
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Research Site
state: California
city: Irvine
country: United States
facility: Research Site
state: California
city: Ocala
country: United States
facility: Research Site
state: Florida
city: Austin
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Herston
country: Australia
facility: Research Site
state: Queensland
city: Adelaide
country: Australia
facility: Research Site
state: South Australia
city: Prahran
country: Australia
facility: Research Site
state: Victoria
city: Christchurch
country: New Zealand
facility: Research Site
city: Grafton, Auckland
country: New Zealand
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: