Bone turnover markers and pharmacokinetics of a new sustained-release formulation of the cathepsin K inhibitor, ONO-5334, in healthy post-menopausal women
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| 024 | 7 | 0 | |a 10.1007/s00774-013-0558-2 |2 doi |
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| 245 | 0 | 0 | |a Bone turnover markers and pharmacokinetics of a new sustained-release formulation of the cathepsin K inhibitor, ONO-5334, in healthy post-menopausal women |h [Elektronische Daten] |c [Shinichi Nagase, Michiyo Ohyama, Yoshitaka Hashimoto, Maria Small, John Sharpe, Junichiro Manako, Tomohiro Kuwayama, Steve Deacon] |
| 520 | 3 | |a A sustained-release tablet (SRT) of ONO-5334 was compared to the immediate-release tablet (IRT) dose, which demonstrated effects on bone mineral density (BMD) comparable to those of therapy with alendronate. The single-dose phase was a randomized, partial single-blind, crossover study where 50-, 100-, and 300-mg SRTs and 300-mg IRTs were administered to nine post-menopausal women. The multiple-dose phase was a randomized, double-blind, placebo-controlled, parallel-group study where 100- and 300-mg SRTs, or placebo were administered to 24 women. After a single administration of a 300-mg SRT, mean C max was 3.3-fold lower, mean AUCinf was 0.83-fold lower and mean C 24h was 5.4-fold higher compared to the 300-mg IRT. Repeated SRT dosing did not significantly affect PK, although C 24h increased slightly. After a single ONO-5334 dose, serum CTX-I was suppressed by ~50% within 1h, reaching maximum suppression 6h post-dose. Greater suppression was maintained longer by the 300-mg SRT vs. the 300-mg IRT. Second morning void and cumulative urine CTX-I showed clear dose-response effects at/over 24h for SRT, with maximum suppression occurring at/over 24h (except 50- and 300-mg cumulative urine). Repeated dosing suggested greater suppression of urine CTX-I. Compared with the IRT, the SRT showed reduced C max, greater C 24h, and slightly reduced AUCinf dose for dose. The SRT showed clear dose-response suppression on bone resorption and greater efficacy dose for dose vs. the IRT. | |
| 540 | |a The Japanese Society for Bone and Mineral Research and Springer Japan, 2014 | ||
| 690 | 7 | |a Cathepsin K inhibitor |2 nationallicence | |
| 690 | 7 | |a Osteoporosis |2 nationallicence | |
| 690 | 7 | |a Sustained-release formulation |2 nationallicence | |
| 690 | 7 | |a CTX-I |2 nationallicence | |
| 690 | 7 | |a ONO-5334 |2 nationallicence | |
| 700 | 1 | |a Nagase |D Shinichi |u Drug Development, ONO PHARMA UK LTD, MidCity Place, 71 High Holborn, WC1V 6EA, London, UK |4 aut | |
| 700 | 1 | |a Ohyama |D Michiyo |u Clinical Development Planning, Ono Pharmaceutical Co., Ltd., 8-2, Kyutaromachi, Chuo-ku, 1-chome, 541-8564, Osaka, Japan |4 aut | |
| 700 | 1 | |a Hashimoto |D Yoshitaka |u Pharmacokinetic Research Group, Ono Pharmaceutical Co., Ltd., 17-2 Wadai, 300-4247, Tsukuba, Ibaraki, Japan |4 aut | |
| 700 | 1 | |a Small |D Maria |u Drug Development, ONO PHARMA UK LTD, MidCity Place, 71 High Holborn, WC1V 6EA, London, UK |4 aut | |
| 700 | 1 | |a Sharpe |D John |u Drug Development, ONO PHARMA UK LTD, MidCity Place, 71 High Holborn, WC1V 6EA, London, UK |4 aut | |
| 700 | 1 | |a Manako |D Junichiro |u Clinical Development Planning, Ono Pharmaceutical Co., Ltd., 8-2, Kyutaromachi, Chuo-ku, 1-chome, 541-8564, Osaka, Japan |4 aut | |
| 700 | 1 | |a Kuwayama |D Tomohiro |u Drug Development, ONO PHARMA UK LTD, MidCity Place, 71 High Holborn, WC1V 6EA, London, UK |4 aut | |
| 700 | 1 | |a Deacon |D Steve |u Drug Development, ONO PHARMA UK LTD, MidCity Place, 71 High Holborn, WC1V 6EA, London, UK |4 aut | |
| 773 | 0 | |t Journal of Bone and Mineral Metabolism |d Springer Japan |g 33/1(2015-01-01), 93-100 |x 0914-8779 |q 33:1<93 |1 2015 |2 33 |o 774 | |
| 856 | 4 | 0 | |u https://doi.org/10.1007/s00774-013-0558-2 |q text/html |z Onlinezugriff via DOI |
| 898 | |a BK010053 |b XK010053 |c XK010000 | ||
| 900 | 7 | |a Metadata rights reserved |b Springer special CC-BY-NC licence |2 nationallicence | |
| 908 | |D 1 |a research-article |2 jats | ||
| 949 | |B NATIONALLICENCE |F NATIONALLICENCE |b NL-springer | ||
| 950 | |B NATIONALLICENCE |P 856 |E 40 |u https://doi.org/10.1007/s00774-013-0558-2 |q text/html |z Onlinezugriff via DOI | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Nagase |D Shinichi |u Drug Development, ONO PHARMA UK LTD, MidCity Place, 71 High Holborn, WC1V 6EA, London, UK |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Ohyama |D Michiyo |u Clinical Development Planning, Ono Pharmaceutical Co., Ltd., 8-2, Kyutaromachi, Chuo-ku, 1-chome, 541-8564, Osaka, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Hashimoto |D Yoshitaka |u Pharmacokinetic Research Group, Ono Pharmaceutical Co., Ltd., 17-2 Wadai, 300-4247, Tsukuba, Ibaraki, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Small |D Maria |u Drug Development, ONO PHARMA UK LTD, MidCity Place, 71 High Holborn, WC1V 6EA, London, UK |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Sharpe |D John |u Drug Development, ONO PHARMA UK LTD, MidCity Place, 71 High Holborn, WC1V 6EA, London, UK |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Manako |D Junichiro |u Clinical Development Planning, Ono Pharmaceutical Co., Ltd., 8-2, Kyutaromachi, Chuo-ku, 1-chome, 541-8564, Osaka, Japan |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Kuwayama |D Tomohiro |u Drug Development, ONO PHARMA UK LTD, MidCity Place, 71 High Holborn, WC1V 6EA, London, UK |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Deacon |D Steve |u Drug Development, ONO PHARMA UK LTD, MidCity Place, 71 High Holborn, WC1V 6EA, London, UK |4 aut | ||
| 950 | |B NATIONALLICENCE |P 773 |E 0- |t Journal of Bone and Mineral Metabolism |d Springer Japan |g 33/1(2015-01-01), 93-100 |x 0914-8779 |q 33:1<93 |1 2015 |2 33 |o 774 | ||