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

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.