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

Phase 1CompletedNCT01937260

Bausch Health Americas, Inc.31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Psoriasis

Interventions

BrodalumabDRUG

Group 1 consists of 20 subjects and will receive 2 oral doses of midazolam and a single SC dose of brodalumab. Group 2 consists of 10 subjects and will receive a single SC dose of brodalumab.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (10)

Research Site

Anaheim, California, United States

Research Site

Irvine, California, United States

Research Site

Ocala, Florida, United States

Research Site

Austin, Texas, United States

Outcomes

Primary Outcomes

The Maximum Observed Concentration of Midazolam After a Single Dose of Brodalumab

Midazolam pharmacokinetic parameter estimates after single oral dose of Midazolam 2 mg on Day 1 and Day 9 and a single administration of Brodalumab 210 mg on Day 2 with PK sampling collected on Day 30

Time frame: Day 1 to day 9

The Area Under Drug Concentration Time Curve From Zero to Infinity (AUCinf)

Time frame: Day 1 to Day 9

The Area Under the Drug-concentration Curve of Midazolam After a Single Dose of Brodalumab From Zero Tot he Last Time of Quantifiable Concentration

Midazolam pharmacokinetic parameter estimates after single oral dose of Midazolam 2 mg on Day 1 and Day 9 and a single administration of Brodalumab 210 mg on Day 2

Time frame: Day 1 to Day 9

Data from ClinicalTrials.gov

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