Safety and Drug Absorption of Orally Administered Oleylphosphocholine (OlPC) in Healthy Adults

Exclusion Criteria

• •1. Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia, recurrent, severe infections and chronic immunosuppressant medication (more than 14 days) within the past 6 months.
• •2. Any history of or signs of hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic clinical significant abnormalities.
• •3. History of chronic infections (e.g., hepatitis В or С) and chronic inflammation.
• •4. History of significant, acute or chronic gastrointestinal, hepatic, cardiac or renal disorders.
• •5. History of leishmaniasis.
• •6. History of hypersensitivity to the excipients present in the investigational medicinal product or to any drug with similar chemical structure (Miltefosine).
• •7. Use of immunoglobulins or blood products within 3 months prior to enrolment.
• •8. Receipt of any investigational medicinal product in the 30 days preceding enrolment, or planned receipt during the trial period.
• •9. Participation in other clinical trials or observation period of competing trials.
• •10. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ in the last five years).
• •11. Mental disorders or other psychiatric conditions (including depression).
• •12. The average alcohol intake greater than 24 g pure alcohol per day for men or greater than 12 g pure alcohol per day for women (including history of possible addiction) and alcohol consumption on more than five days a week.
• •13. Suspected or known injecting drug abuse in the 5 years preceding enrolment.
• •14. Participants unable to be closely followed for social, geographic or psychological reasons.
• •15. Any clinically significant abnormal finding on biochemistry or hematology blood tests, urine analysis or clinical examination.
• •16. History of seizure, except for sporadic childhood febrile convulsions.
• •17. Sjoegren-Larsson-Syndrome (SLS).
• •18. Participants who are unwilling to ingest the food provided.
• •19. Any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data