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

Phase 1

Completed

• Conditions: Psoriasis
• Interventions: Drug: Brodalumab

• Registration Number: NCT01937260
• Lead Sponsor: Bausch Health Americas, Inc.

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.

Study Timeline

• Study First Submitted: 2013-07-15
• Study Start: 2013-09
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-09
• Primary Completion: 2014-07
• Study Completion: 2014-12
• Results First Submitted: 2016-11-08
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-07
• Last Update Submitted: 2017-04-07
• Results First Posted: 2017-04-10
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brodalumab 140mg SC	Brodalumab	open label, all subjects receive brodulamab
Midazolam (MDZ) 2mg oral, Brodalumab 210mg SC	Brodalumab	MDZ 2mg oral (Day 1 and Day 9), Brodalumab 210mg SC (Day 2)

Primary Outcome Measures

Name	Time	Method
The Maximum Observed Concentration of Midazolam After a Single Dose of Brodalumab	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
The Area Under the Drug-concentration Curve of Midazolam After a Single Dose of Brodalumab From Zero Tot he Last Time of Quantifiable Concentration	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
The Area Under Drug Concentration Time Curve From Zero to Infinity (AUCinf)	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

Trial Locations

Locations (1)

Research Site; 🇳🇿 Grafton, Auckland, New Zealand