Phase I Clinical Study of a Phosphate binder, PB-94 (Sevelamer Hydrochloride)-A Single Administration-
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Accession number;03A0475551
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| Title;Phase I Clinical Study of a Phosphate binder, PB-94 (Sevelamer Hydrochloride)-A Single Administration- |
| Author;
MIWATANI HIROSHI
(Yakusenkai Kannondaikurinikku)
UCHINO MITSUE
(Yakusenkai Kannondaikurinikku)
AKIZAWA TADAO
(Showa Univ., Fujigaoka Hospital, JPN)
ONISHI AKIHIRO
(Jikei Univ. School of Medicine)
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.19;NO.6;PAGE.547-555(2003)
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| Figure&Table&Reference;FIG.2, TBL.5, REF.3 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;PB-94 is a calcium- and aluminium-free polycation polymer developed for the treatment of hyperphosphatemia in dialysis patients. To confirm safety of the drug and determine its appropriate dose range in single oral administration, PB-94 was given at a single dose of 0.5g, 1.0g, 2.0g, or 4.0g to healthy adult male volunteers in the Phase I clinical study carried out in Japan. The number of the subjects of each dose group was 9 (6 on PB-94 and 3 on placebo), giving a total of 36 subjects. Adverse events were seen in 5 subjects (2 in the PB-94 group and 3 in the placebo group), and abnormal changes in laboratory and physiological data were seen in 8 subjects (5 in the PB-94 group and 3 in the placebo group). Among them, decreased serum iron and increased UIBC seen only in one subject of the PB-94 group were judged to be side effect. These events were not considered to be clinically significant, and it is concluded that the safety of PB-94 is similar to that of placebo. Serum phosphorus levels decreased 2 hours after administration both in the PB-94 and placebo groups, and then showed a pattern to recover. Since no dose dependency was observed in individual dose groups, and a similar decrease in serum phosphorus levels was also seen in the placebo group, the variation was attributed to the circadian rhythm of serum phosphorus levels. No increase in serum calcium levels was confirmed. It is concluded that there is no safety problem up to 4.0g of single administration of PB-94. (author abst.) |
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