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

Moderate to Severe Plaque Psoriasis Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

  • Moderate to Severe Plaque Psoriasis
  • Psoriasis
Clinical Trial Details
NCT number NCT01260844
Study type Interventional
Source Abbott
Contact
Status Withdrawn
Phase Phase 1
Start date April 2011
View Details
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