To evaluate the safety, tolerability and pharmacokinetics of ascending single and multiple doses of CH-4051.
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Adverse events and tolerability
Secondary outcome
Pharmacokinetics
Background summary
CH-4051 is a new anti-folate study drug that inhibits folic acid in the human
body. Folic acid is an important factor in DNA and protein synthesis. Folic
acid is also involved in the production of red blood cells. Anti-folate
medicines (eg, methotrexate) are effective against diseases of rapidly dividing
cells and autoimmune diseases with inflammatory reactions, such as cancer,
arthritis or psoriasis.
Folic acid / folate is an essential vitamin from the vitamin B complex. A human
being can not produce folic acid or folates, and is thus dependent on the
supply of food or food supplements. Sources of folate in the diet are green
leafy vegetables, citrus fruit, yeast and some types of meat, especially liver.
Folic acid is often present in fortified foods and dietary supplements (multi
vitamin / mineral tablets).
Study objective
To evaluate the safety, tolerability and pharmacokinetics of ascending single
and multiple doses of CH-4051.
Study design
Randomised, double-blind, placebo-controlled, single and multiple ascending
doses
Study burden and risks
The risks during this trial are the possible side effects related to the study
medication.
Also the admission period, venapunctures and placing the canula may cause a
burden to the volunteers
Other assessments taking place during this trial: physical examination, vital
signs, ECG, cardiac monitoring, blood and urine collection, drug screen,
alcohol test and study restrictions.
All volunteers are being monitored by experienced physicians and study
personell.
3530 Toringdon Way, Suite 200
Charlotte, N.C. 28277
USA
3530 Toringdon Way, Suite 200
Charlotte, N.C. 28277
USA
Listed location countries
Age
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
• 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-005524-85-NL |
| CCMO | NL24989.040.08 |