Open Label, Single Dose, Non-randomized Study to Assess the Drug to Drug Interaction of Briakinumab on CYP Substrates.
- Registration Number
- NCT01260844
- Lead Sponsor
- Abbott
- Brief 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description single dose of briakinumab briakinumab single dose briakinumab cocktail of CYP substrates
- Primary Outcome Measures
Name Time Method Assessment of the drug-drug interaction potential of briakinumab (ABT-874) with cytochrome CYP 1A2. CYP2C9, CYP2C19, CYP2D6 and CYP3A4 in moderate to severe plaque psoriasis subjects 17 days CYP Substrate cocktail administed at Day -1 and day 14 and Briakinumab at Day 1
- Secondary Outcome Measures
Name Time Method No secondary outcomes are reported for this study No secondary outcomes are reported for this study No secondary outcomes are reported for this study