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Completed

NCT Number: NCT01937260

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

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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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Herston, Queensland, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brodalumab

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.

Other names: AMG 827

Primary outcomes

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

    Time frame: Day 1 to day 9

    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

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

    Time frame: Day 1 to Day 9

    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

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

    Time frame: Day 1 to Day 9

    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

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 9, 2013
Registry last updated
Apr 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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