NCT01260844

Open Label, Single Dose, Non-randomized Study to Assess the Drug to Drug Interaction of Briakinumab on CYP Substrates.

An Open-Label Study to Evaluate the Effect of a Single Dose of Briakinumab on the Pharmacokinetics of Single Doses of Caffeine, Tolbutamide, Omeprazole, Metroprolol, and Midazolam in Subjects With Moderate to Severe Psoriasis

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Phase 1, drug-drug interaction study to evaluate the effects of Briakinumab on hte pharmacokinetics of single doses of CYP substrate in subjects with moderate to severe psoriasis.

Detailed description

The study does involve 3 days confinement at the beginning of the trial and 4 days at the end of the trial. The trial duration is 17 days with 6 visits not including the confinement periods. The trial is being conducted in moderate to severe plaque psoriasis subjects. Serial blood samples will be taken after each doses of the CYP substrates are administered and blood samples will be collected for briakinumab PK and briakinumab ADA.

Conditions

• Moderate to Severe Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	briakinumab	single dose briakinumab and 2 doses of CYP substrates

Timeline

• Start date: 2011-04-01
• First posted: 2010-12-15
• Last updated: 2011-10-21