NCT01937260

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2013

Geographic Reach
3 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

April 10, 2017

Completed
Last Updated

April 10, 2017

Status Verified

April 1, 2017

Enrollment Period

10 months

First QC Date

July 15, 2013

Results QC Date

November 8, 2016

Last Update Submit

April 7, 2017

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Brodalumab 140mg SC

EXPERIMENTAL

open label, all subjects receive brodulamab

Drug: Brodalumab

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

EXPERIMENTAL

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

Drug: Brodalumab

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.

Also known as: AMG 827
Brodalumab 140mg SCMidazolam (MDZ) 2mg oral, Brodalumab 210mg SC

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Research Site

Anaheim, California, 92801, United States

Location

Research Site

Irvine, California, 92697, United States

Location

Research Site

Ocala, Florida, 34471, United States

Location

Research Site

Austin, Texas, 78759, United States

Location

Research Site

Dallas, Texas, 75231, United States

Location

Research Site

Herston, Queensland, 4006, Australia

Location

Research Site

Adelaide, South Australia, 5000, Australia

Location

Research Site

Prahran, Victoria, 3181, Australia

Location

Research Site

Christchurch, 8011, New Zealand

Location

Research Site

Grafton, Auckland, 1010, New Zealand

Location

Related Links

MeSH Terms

Conditions

Psoriasis

Interventions

brodalumab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Director of Clinical Trials
Organization
Valeant Pharmaceuticals
binu.alexander@valeant.com
908

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2013

First Posted

September 9, 2013

Study Start

September 1, 2013

Primary Completion

July 1, 2014

Study Completion

December 1, 2014

Last Updated

April 10, 2017

Results First Posted

April 10, 2017

Record last verified: 2017-04

Locations

NZ(2)US(5)AU(3)