抄録
Single and 7-day multiple dose studies of MK-217, a new aminobisphosphonate, were conducted on 5 Japanese postmenopausal female volunteers. The safety of the drug, pharmacokinetics and its effects on biochemical markers of bone turnover were inves tigated.
In the single dose study, 10 mg of MK-217 was administered to 5 subjects 2 hours before breakfast and in the 7-day multiple dose study, the same dose of MK-217 was administered one-half hour before breakfast.
No abnormal changes were observed in subjective symptoms, blood pressure, pulse rate, respiratory rate, body temperature, ECG and body weight in both studies. In the 7-day multiple dose study, an increase in alkaline phosphatase (Al-p) was observed in one subject. The relationship of this phenomenon to the drug was unknown. Following the 7-day multiple dose study, serum osteocalcin (CIS method) and urinary pyridinoline (deoxy-and hydroxylysyl pyridinoline) were decreased significantly.
Less than 1% of the administered dose of MK-217 was excreted in urine in both studies, although the excretion rate was higher in the single dose study than in the multiple dose study.
