A phase 1, first human exposure, single dose, double-blind, randomized, placebo controlled trial to assess the safety, tolerability, pharmacokinetics and pharmaco-dynamics after oral administration of Org 48775-0 in healthy male volunteers in fasted and fed state, in female healthy volunteers, and in rheumatoid arthritis patients with active disease while on methotrexate treatment.
Completed
- Conditions
- Rheumatoid arthritis10003816
- Registration Number
- NL-OMON32271
- Lead Sponsor
- Organon Nederland BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Male volunteers: healthy
Female volunteers: healthy and post-menopausal
Patients: active disease and treatment with MTX
Exclusion Criteria
Volunteers: clinically significant abnormalities (females: possible fertile)
Patients: clinically significant abnormalities (females: possible fertile) and recent treatment with anti-TNF therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetics of drug<br /><br>Pharmacodynamics of drug (ao measurement of inhibition in TNF-release after<br /><br>ex-vivo LPS stimulation)<br /><br>Routine clinical annd lab parameters</p><br>
- Secondary Outcome Measures
Name Time Method <p>Transcriptomics / Proteomics </p><br>