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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01937260
• Other study ID #: 20110184
• Status: Completed
• Phase: Phase 1
• First received: July 15, 2013
• Last updated: April 7, 2017
• Start date: September 2013
• Est. completion date: December 2014

Study information

• Verified date: April 2017
• Source: Valeant Pharmaceuticals International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Valeant Pharmaceuticals International, Inc.

Countries where clinical trial is conducted

United States,  Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 1 to day 9
Primary	The Area Under Drug Concentration Time Curve From Zero to Infinity (AUCinf)	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	Day 1 to Day 9
Primary	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	Day 1 to Day 9

External Links

•   AmgenTrials clinical trials website