Pharmacokinetics and safety assessments of high-dose and 4-week treatment with S-3304, a novel matrix metalloproteinase inhibitor, in healthy volunteers

British Journal of Clinical Pharmacology

Volumn 63, Issue 5, 2007, Pages 512-526

  Mant, Timothy G K ^b   Bradford, Daniel ^b   Amin, Dipti M ^b   Pisupati, Jaya ^b   Kambayashi, Yoshikazu ^a   Yano, Yoshitaka ^a   Tanaka, Kazushige ^a   Yamada Sawada, Takuko ^a  

^a SHIONOGI AND CO LTD   (Japan)

^b IQVIA   (United States)

Author keywords

ALT; Matrix metalloproteinase; Pharmacokinetics; Phase I; S 3304; Safety

Indexed keywords

MATRIX METALLOPROTEINASE INHIBITOR; PLACEBO; S 3304; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ADULT; ADVERSE OUTCOME; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALOPECIA; ARTICLE; BACKACHE; BLURRED VISION; CHEMICAL ANALYSIS; CLINICAL EXAMINATION; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; DIZZINESS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG MEGADOSE; DRUG SAFETY; DRUG SCREENING; DRUG TOLERABILITY; DRUG TOLERANCE; DRUG WITHDRAWAL; ELECTROCARDIOGRAM; FEMALE; HEADACHE; HEMATOCHEZIA; HEMATOLOGY; HUMAN; LABORATORY TEST; LETHARGY; LIVER FUNCTION TEST; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; NAUSEA; NORMAL HUMAN; NOSE CONGESTION; PHASE 1 CLINICAL TRIAL; POSITIONAL DIZZINESS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; SEX RATIO; SIDE EFFECT; SORE THROAT; STATISTICAL SIGNIFICANCE; URINARY FREQUENCY; VITAL SIGN;

ADULT; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; ENZYME INHIBITORS; FEMALE; HUMANS; INDOLES; MALE; MATRIX METALLOPROTEINASES; THIOPHENES;

EID: 34247543100     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2006.02794.x     Document Type: Article

References (36)

1. Woessner JF Jr. Matrix metalloproteinases and their inhibitors in connective tissue remodeling. FASEB J 1991 5 : 2145 54.
2. Docherty AJ, O'Connell J, Crabbe T, Angal S, Murphy G. The matrix metalloproteinases and their natural inhibitors: prospects for treating degenerative tissue diseases. Trends Biotechnol 1992 10 : 200 7.
3. Gordon JL, Drummond AH, Galloway WA. Metalloproteinase inhibitors as therapeutics. Clin Exp Rheumatol 1993 11 : S91 4.
4. Wojtowicz-praga SM, Dickson RB, Hawkins MJ. Matrix metalloproteinase inhibitors. Invest New Drugs 1997 15 : 61 75.
5. Nagase H, Woessner JF Jr. Matrix metalloproteinases. J Biol Chem 1999 274 : 21491 4.
6. Iizawa T, Fujisawa T, Suzuki M, Motohashi S, Yasufuku K, Yasukawa T, Baba M, Shiba M. Elevated levels of circulating plasma matrix metalloproteinase 9 in non-small cell lung cancer patients. Clin Cancer Res 1999 5 : 149 53.
7. Brown PD, Bloxidge RE, Stuart NSA, Gatter KC, Carmichael J. Association between expression of activated 72-kilodalton gelatinase and tumor spread in non-small cell lung carcinoma. J Natl Cancer Inst 1993 85 : 574 8.
8. Zucker S, Lysik RM, Zarrabi MH, Moll U. Mr 92,000 type IV collagenase is increased in plasma of patients with colon and breast cancer. Cancer Res 1993 53 : 140 6.
9. Djonov V, Cresto N, Aebersold DM, Burri PH, Altermatt HJ, Hristic M, Berclaz G, Ziemiecki A, Andres AC. Tumor cell specific expression of MMP-2 correlates with tumor vascularisation in breast cancer. Int J Oncol 2002 21 : 25 30.
10. Gerhards S, Jung K, Koenig F, Daniltchenko D, Hauptmann S, Schnorr D, Loening SA. Excretion of matrix metalloproteinases 2 and 9 in urine is associated with a high stage and grade of bladder carcinoma. Urology 2001 57 : 675 9.
11. Nordqvist AC, Smurawa H, Mathiesen T. Expression of matrix metalloproteinases 2 and 9 in meningiomas associated with different degrees of brain invasiveness and edema. J Neurosurg 2001 95 : 839 44.
12. Kanoh Y, Akahoshi T, Ohara T, Ohtani N, Mashiko T, Ohtani S, Egawa S, Baba S. Expression of matrix metalloproteinase-2 and prostate-specific antigen in localized and metastatic prostate cancer. Anticancer Res 2002 22 : 1813 7.
13. Matrisian LM. Metalloproteinases and their inhibitors in matrix remodelling. Trends Genet 1993 6 : 121 5.
14. MacDougall Jr., Matrisian LM. Contribution of tumor and stromal matrix metalloproteinases to tumor progression, invasion and metastasis. Cancer Metastasis Rev 1995 141 : 351 62.
15. Li BH, Zhao P, Liu SH, Yu YM, Han M, Wen JK. Matrix metalloproteinase-2 and tissue inhibitor of metalloproteinase-2 in colorectal carcinoma invasion and metastasis. World J Gastroenterol 2005 28 : 3046 50.
16. Altieri P, Brunelli C, Garbaldi S, Nicolino A, Spallarossa P, Olivotti L, Rossettin P, Barsotti A, Ghigliotti G. Metalloproteinases 2 and 9 are increased in plasma of patients with heart failure. Eur J Clin Invest 2003 33 : 648 56.
17. Leighl NB, Paz-ares L, Douillard JY, Peschel C, Arnold A, Depierre A, Santoro A, Betticher DC, Gatzemeier U, Jassem J, Crawford J, Tu D, Bezjak A, Humphrey JS, Voi M, Galbraith S, Hann K, Seymour L, Shepherd FA. Randomized phase III study of matrix metalloproteinase inhibitor BMS-275291 in combination with paclitaxel and carboplatin in advanced non-small-cell lung cancer. National Cancer Institute of Canada-Clinical Trials Group Study BR 18. J Clin Oncol 2005 23 : 2831 9.
18. Bissett D, O'Byrne KJ, von Pawel J, Gatzemeier U, Price A, Nicolson M, Ercier R, Mazabel E, Penning C, Zhang MH, Collier MA, Shepherd FA. Phase III study of matrix metalloproteinase inhibitor prinomastat in non-small-cell lung cancer. J Clin Oncol 2005 23 : 842 9.
19. Sparano JA, Bernardo P, Stephenson P, Gradishar WJ, Ingle JN, Zucker S, Davidson NE. Randomized phase III trial of marimastat versus placebo in patients with metastatic breast cancer who have responding or stable disease after first-line chemotherapy: Eastern Cooperative Oncology Group trial E2196. J Clin Oncol 2004 22 : 4683 90.
20. Moore MJ, Hamm J, Dancey J, Eisenberg PD, Dagenais M, Fields A, Hagan K, Greenberg B, Colwell B, Zee B, Tu D, Ottaway J, Humphrey R, Seymour L. Comparison of gemcitabine versus the matrix metalloproteinase inhibitor BAY 12-9566 in patients with advanced or metastatic adenocarcinoma of the pancreas: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 2003 21 : 3296 302.
21. Bramhall SR, Hallissey MT, Whiting J, Scholefield J, Tierney G, Stuart RC, Hawkins RE, McCulloch P, Maughan T, Brown PD, Baillet M, Fielding JW. Marimastat as maintenance therapy for patients with advanced gastric cancer: a randomised trial. Br J Cancer 2002 86 : 1864 70.
22. King J, Zhao J, Clingan P, Morris D. Randomised double blind placebo control study of adjuvant treatment with the metalloproteinase inhibitor, marimastat, in patients with inoperable colorectal hepatic metastases: significant survival advantage in patients with musculoskeletal side-effects. Anticancer Res 2003 23 : 639 45.
23. Shepherd FA, Giaccone G, Seymour L, Debruyne C, Bezjak A, Hirsh V, Smylie M, Rubin S, Martins H, Lamont A, Krzakowski M, Sadura A, Zee B. Prospective, randomized, double-blind, placebo-controlled trial of marimastat after response to first-line chemotherapy in patients with small-cell lung cancer. a trial of the National Cancer Institute of Canada-Clinical Trials Group and the European Organization for Research and Treatment of Cancer. J Clin Oncol 2002 20 : 4434 9.
24. Brown PD. Ongoing trials with matrix metalloproteinase inhibitors. Expert Opin Invest Drug 2000 9 : 2167 77.
25. Shalinsky DR, Shetty B, Pithavala Y, Bender S, Neri A, Webber S, Appelt K, Collier M. Prinomastat, a potent and selective matrix metalloproteinase inhibitor - preclinical and clinical development for oncology. In : Cancer Drug Discovery and Development: Matrix Metalloproteinase Inhibitors in Cancer Therapy, eds. Clendeninn NJ, Appelt K. Totowa, New Jersey : Humana Press, 2000 : 143 73.
26. Tamura Y, Watanabe F, Nakatani T, Yasui K, Fuji M, Komurasaki T, Tsuzuki H, Maekawa R, Yoshioka T, Kawada K, Sugita K, Ohtani M. Highly selective and orally active inhibitors of type IV collagenase (MMP-9 and MMP-2): N-sulfonylamino acid derivatives. J Med Chem 1998 41 : 640 9.
27. van Marle S, van Vliet A, Sollie F, Kambayashi Y, Yamada-Sawada T. Safety, tolerability and pharmacokinetics of oral S-3304, a novel matrix metalloproteinase inhibitor, in single and multiple dose escalation studies in healthy volunteers. Int J Clin Pharm Ther 2005 43 : 282 93.
28. Lima JJ, Mackichan JJ, Libertin N, Sabino J. Influence of volume shifts on drug binding during equilibrium dialysis: correction and attenuation. J Pharmacokinet Biopharm 1983 11 : 483 98.
29. Gough K, Hutchinson M, Keene O, Byrom B, Ellis S, Lacey L, McKellar J. Assessment of dose proportionality: report from the statisticians in the pharmaceutical industry/pharmacokinetics UK Joint Working Party. Drug Inform J 1995 29 : 1039 48.
30. Iwahori T, Takeuchi H, Matsuno N, Johjima Y, Konno O, Nakamura Y, Hama K, Uchiyama M, Ashizawa T, Okuyama K, Nagao T, Abudoshukur M, Hirano T, Oka K. Pharmacokinetic differences between morning and evening administration of cyclosporine and tacrolimus therapy. Transplant Proc 2005 37 : 1739 40.
31. Creaven PJ, Sullivan DM, Gail-Eckhardt S, Bukowski R, Bonomi P, Rao S, Ikeda M, Kambayashi Y, Yamada-Sawada T, Ohtani M. A phase I study of S-3304 a matrix metalloproteinase inhibitor in patients with solid tumors. Eur J Cancer 2002 38 : S77.
32. Takeuchi M, Nezasa K, Kawahara S, Inazawa K, Baba T, Sakamoto K, Koike M, Yoshikawa T. Non-clinical assessments of drug metabolism and pharmacokinetics of S-3304, a matrix metalloproteinase inhibitor. Eur J Cancer 2002 38 : S72.
33. Holtmann M, Meyer AE, Pitzer M, Schmidt MN. Risperidone-induced marked elevation of serum creatine kinase in adolescence. A case report. Pharmacopsychiatry 2003 36 : 317 8.
34. Richter JG, Becker A, Ostendorf B, Specker C, Stoll G, Neuen-Jacob E, Schneider M. Differential diagnosis of high serum creatine kinase levels in systemic lupus erythematosus. Rheumatol Int 2003 23 : 319 23.
35. Fung HB, Guo Y. Enfuvirtide: a fusion inhibitor for the treatment of HIV infection. Clin Ther 2004 26 : 352 78.
36. Kato I, Yoshida T, Muranaka R, Kondo K, Miyake Y, Hirose H, Sameshima H, Izumi H. Non-clinical assessments of safety profiles of S-3304, a novel matrix metalloproteinase inhibitor. Eur J Cancer 2002 38 : S76.