ClinicalTrials.Veeva

Menu

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

Bausch Health logo

Bausch Health

Status and phase

Completed
Phase 1

Conditions

Psoriasis

Treatments

Drug: Brodalumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01937260
20110184

Details and patient eligibility

About

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.

Full 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.

Enrollment

31 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

31 participants in 2 patient groups

Brodalumab 140mg SC
Experimental group
Description:
open label, all subjects receive brodulamab
Treatment:
Drug: Brodalumab
Midazolam (MDZ) 2mg oral, Brodalumab 210mg SC
Experimental group
Description:
MDZ 2mg oral (Day 1 and Day 9), Brodalumab 210mg SC (Day 2)
Treatment:
Drug: Brodalumab

Trial contacts and locations

10

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems