rheumatoid arthritis
Conditions
Interventions
None listed
Sponsors
Chelsea Therapeutics, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • written informed consent • males, 18-55 years of age • physically and mantally in good state of health • body mass index of 18-30 kg/m2 • no abnormalities found at screening
Exclusion criteria
Exclusion criteria: • smoking or stopped smoking less than three months ago • drugs and/or alcohol abuse • drinking more than 21 glasses of alcohol per week • surgery in 3 months prior to study • hepatitis B, C or HIV positive • no history of infection with chicken pox • planning to be vaccinated with a (live) vaccine (yellow fever, MMR, and rubella) during the study • use of prescription medication within 4 weeks prior to the first dosing day • previously or currently receiving MTX • use of over-the-counter medication within 2 weeks prior to the first dosing day • vegetarians, vegans and/or having medical dietary restrictions • relevant food or drug hypersensitivity or allergy • having participated in an investigational drug study within 3 months prior to the dosing day • having donated blood within 12 weeks prior to the (first) dosing day • having a significant infection at screening • having an active viral, bacterial or fungal infection on day -1 • raised body temperature (>38 degrees celsius) on day -1 • taking co-trimoxazole or thrimethoprim • MCV > 95 fL • acute significant gastrointestinal symptoms on day -1 or prior to dosing on day 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events and tolerability | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | — |
Countries
Netherlands
Outcome results
None listed