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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Brodalumab 140mg SC

open label, all subjects receive brodulamab

Group Type EXPERIMENTAL

Brodalumab

Intervention Type DRUG

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.

Midazolam (MDZ) 2mg oral, Brodalumab 210mg SC

MDZ 2mg oral (Day 1 and Day 9), Brodalumab 210mg SC (Day 2)

Group Type EXPERIMENTAL

Brodalumab

Intervention Type DRUG

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.

Interventions

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Brodalumab

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.

Intervention Type DRUG

Other Intervention Names

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AMG 827

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No