a study of ccx168 in japanese and caucasian healthy adult males

Conditions: Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis

Summary: the objectives of the study will be to investigate the safety and pharmacokinetics of a single oral administration and a twice-daily multiple oral administration of ccx168 in japanese healthy adult males; and to compare the pharmacokinetics of a single oral administration and a twice-daily multiple oral administration of ccx168 between japanese and caucasian healthy adult males.


Eligibility criteria:
inclusion criteria: * japanese and caucasian healthy males aged 20 to 45 years inclusive (at the time of obtaining informed consent); * body mass index (body weight \[kg\]/squared height \[m\^2\]): 18.5 kg/m\^2 or more and less than 25 kg/m\^2 for japanese males or between 18.5 and 29 kg/m\^2 for caucasian males (at the time of screening visit); * body weight: 50 kg or more and less than 90 kg (at the time of screening visit). exclusion criteria: * participants with any abnormal findings (e.g., clinical laboratory test values outside the reference range) during the physical examination and other tests (vital signs, 12-lead ecg and clinical laboratory tests) that are judged by the principal investigator or subinvestigator to be clinically significant; * participants who test positive for immunological tests (hepatitis b surface antigen, hepatitis c virus antibody, serological reaction of syphilis, and human immunodeficiency virus antigen and antibody); * participants with a history of drug allergy; * participants who are a habitual alcohol drinker with an average pure alcohol intake of over 40 g/day; * participants who test positive for abuse of phencyclidines, benzodiazepines, cocaine, stimulants, cannabis, morphine, barbiturates, and tricyclic antidepressants during urine drug testing; * male participant who do not agree to use adequate contraception for a period from a start of the investigational product administration to 12 weeks after the final administration of the investigational product; * participants with a qtcf intervals of 450 msec or greater in the 12-lead ecg at the time of the screening visit and/or day -1; * participants who consumed tobacco or a nicotine patch/gum within 12 weeks prior to the investigational product administration; * participants who received other prescription medications or over-the-counter medications (including vitamins and energy drinks) within 2 weeks prior to the investigational product administration (excluding topical formulation that is not expected systemic action); * participants who received any supplements (saint john's wort \[hypericum perforatum\] etc.) that have been reported to affect the pharmacokinetics of concomitant use of drugs within 2 weeks prior to the investigational product administration; * participants who received a grapefruit and an orange that contain the component inhibiting cyp3a4 or the food and drink containing these fruits within 1 week prior to the investigational product administration; * participants who received other investigational products within 16 weeks prior to the investigational product administration; * participants who donated more than 200 ml of blood (donation of whole blood, plasma components or platelets, etc.) within 4 weeks or more than 400 ml within 16 weeks prior to the investigational product administration; * participants who performed excessive exercise with symptoms of fatigue or muscle pain within 1 week prior to the investigational product administration; * participants who are judged by the principal investigator or subinvestigator as inappropriate for inclusion in this study.

Keywords: human c5a receptor (c5ar) vasculitis complement vascular disease