메뉴 건너뛰기




Volumn 32, Issue 7, 2010, Pages 1372-1386

An open-label, randomized, single-center, two-period, phase I, crossover study of the effect of zibotentan (ZD4054) on the pharmacokinetics of midazolam in healthy male volunteers

Author keywords

CYP3A4; Midazolam; Pharmacokinetics; Prostate cancer; ZD4054; Zibotentan

Indexed keywords

1 HYDROXY MIDAZOLAM; 4 HYDROXY MIDAZOLAM; CYTOCHROME P450 3A4; DRUG METABOLITE; MIDAZOLAM; N (3 METHOXY 5 METHYL 2 PYRAZINYL) 2 [4 (1,3,4 OXADIAZOL 2 YL)PHENYL] 3 PYRIDINESULFONAMIDE; UNCLASSIFIED DRUG;

EID: 77955262859     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2010.07.013     Document Type: Article
Times cited : (5)

References (35)
  • 2
    • 2442681667 scopus 로고    scopus 로고
    • Prostate cancer incidence and mortality rates and trends in the United States and Canada
    • McDavid K, Lee J, Fulton JP, et al. Prostate cancer incidence and mortality rates and trends in the United States and Canada. Public Health Rep. 2004, 119:174-186.
    • (2004) Public Health Rep. , vol.119 , pp. 174-186
    • McDavid, K.1    Lee, J.2    Fulton, J.P.3
  • 3
    • 29944434214 scopus 로고    scopus 로고
    • Therapeutic options in androgen-independent prostate cancer: Building on docetaxel
    • Petrylak D Therapeutic options in androgen-independent prostate cancer: Building on docetaxel. BJU Int. 2005, 96(Suppl 2):41-46.
    • (2005) BJU Int. , vol.96 , Issue.SUPPL 2 , pp. 41-46
    • Petrylak, D.1
  • 4
    • 33646475297 scopus 로고    scopus 로고
    • Mechanisms leading to the development of hormone-resistant prostate cancer
    • vii
    • Kasper S, Cookson MS Mechanisms leading to the development of hormone-resistant prostate cancer. Urol Clin North Am. 2006, 33:201-210. vii.
    • (2006) Urol Clin North Am. , vol.33 , pp. 201-210
    • Kasper, S.1    Cookson, M.S.2
  • 5
    • 33646475297 scopus 로고    scopus 로고
    • Mechanisms leading to the development of hormone-resistant prostate cancer
    • Kasper S, Cookson MS Mechanisms leading to the development of hormone-resistant prostate cancer. Urol Clin North Am. 2006, 33:vii.
    • (2006) Urol Clin North Am. , vol.33
    • Kasper, S.1    Cookson, M.S.2
  • 6
    • 4744337716 scopus 로고    scopus 로고
    • Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer
    • Petrylak DP, Tangen CM, Hussain MH, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004, 351:1513-1520.
    • (2004) N Engl J Med. , vol.351 , pp. 1513-1520
    • Petrylak, D.P.1    Tangen, C.M.2    Hussain, M.H.3
  • 7
    • 4744366279 scopus 로고    scopus 로고
    • Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer
    • TAX 327 Investigators
    • Tannock IF, de Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004, 351:1502-1512. TAX 327 Investigators.
    • (2004) N Engl J Med. , vol.351 , pp. 1502-1512
    • Tannock, I.F.1    de Wit, R.2    Berry, W.R.3
  • 8
    • 2942659890 scopus 로고    scopus 로고
    • Targeting endothelin axis in cancer
    • Bagnato A, Natali PG Targeting endothelin axis in cancer. Cancer Treat Res. 2004, 119:293-314.
    • (2004) Cancer Treat Res. , vol.119 , pp. 293-314
    • Bagnato, A.1    Natali, P.G.2
  • 10
    • 23244454378 scopus 로고    scopus 로고
    • Endothelin-1 inhibits apoptosis in prostate cancer
    • Nelson JB, Udan MS, Guruli G, Pflug BR Endothelin-1 inhibits apoptosis in prostate cancer. Neoplasia. 2005, 7:631-637.
    • (2005) Neoplasia. , vol.7 , pp. 631-637
    • Nelson, J.B.1    Udan, M.S.2    Guruli, G.3    Pflug, B.R.4
  • 11
    • 22044435149 scopus 로고    scopus 로고
    • Specific inhibition of the endothelin A receptor with ZD4054: Clinical and preclinical evidence
    • Morris CD, Rose A, Curwen J, et al. Specific inhibition of the endothelin A receptor with ZD4054: Clinical and preclinical evidence. Br J Cancer. 2005, 92:2148-2152.
    • (2005) Br J Cancer. , vol.92 , pp. 2148-2152
    • Morris, C.D.1    Rose, A.2    Curwen, J.3
  • 12
    • 0038407691 scopus 로고    scopus 로고
    • Emerging role of endothelin-1 in tumor angiogenesis
    • Bagnato A, Spinella F Emerging role of endothelin-1 in tumor angiogenesis. Trends Endocrinol Metab. 2003, 14:44-50.
    • (2003) Trends Endocrinol Metab. , vol.14 , pp. 44-50
    • Bagnato, A.1    Spinella, F.2
  • 13
    • 34250691430 scopus 로고    scopus 로고
    • Epithelialmesenchymal transition in ovarian cancer progression: A crucial role for the endothelin axis
    • Bagnato A, Rosanò L Epithelialmesenchymal transition in ovarian cancer progression: A crucial role for the endothelin axis. Cells Tissues Organs. 2007, 185:85-94.
    • (2007) Cells Tissues Organs. , vol.185 , pp. 85-94
    • Bagnato, A.1    Rosanò, L.2
  • 14
    • 0035890357 scopus 로고    scopus 로고
    • Endothelin-1 induces tumor proteinase activation and invasiveness of ovarian carcinoma cells
    • Rosanò L, Varmi M, Salani D, et al. Endothelin-1 induces tumor proteinase activation and invasiveness of ovarian carcinoma cells. Cancer Res. 2001, 61:8340-8346.
    • (2001) Cancer Res. , vol.61 , pp. 8340-8346
    • Rosanò, L.1    Varmi, M.2    Salani, D.3
  • 15
    • 0037303203 scopus 로고    scopus 로고
    • Role of endothelin-1 in osteoblastic bone metastases
    • Guise TA, Yin JJ, Mohammad KS Role of endothelin-1 in osteoblastic bone metastases. Cancer. 2003, 97(Suppl 3):779-784.
    • (2003) Cancer. , vol.97 , Issue.SUPPL 3 , pp. 779-784
    • Guise, T.A.1    Yin, J.J.2    Mohammad, K.S.3
  • 16
    • 0032524338 scopus 로고    scopus 로고
    • Endothelin-induced apoptosis of A375 human melanoma cells
    • Okazawa M, Shiraki T, Ninomiya H, et al. Endothelin-induced apoptosis of A375 human melanoma cells. J Biol Chem. 1998, 273:12584-12592.
    • (1998) J Biol Chem. , vol.273 , pp. 12584-12592
    • Okazawa, M.1    Shiraki, T.2    Ninomiya, H.3
  • 17
    • 24944494039 scopus 로고    scopus 로고
    • Role of endothelin axis in progression to aggressive phenotype of prostate adenocarcinoma
    • Godara G, Cannon GW, Cannon GM, et al. Role of endothelin axis in progression to aggressive phenotype of prostate adenocarcinoma. Prostate. 2005, 65:27-34.
    • (2005) Prostate. , vol.65 , pp. 27-34
    • Godara, G.1    Cannon, G.W.2    Cannon, G.M.3
  • 18
    • 0035133490 scopus 로고    scopus 로고
    • Expression of endothelin receptor a associated with prostate cancer progression
    • Gohji K, Kitazawa S, Tamada H, et al. Expression of endothelin receptor a associated with prostate cancer progression. J Urol. 2001, 165:1033-1036.
    • (2001) J Urol. , vol.165 , pp. 1033-1036
    • Gohji, K.1    Kitazawa, S.2    Tamada, H.3
  • 19
    • 33744928079 scopus 로고    scopus 로고
    • ZD4054, a potent endothelin receptor A antagonist, inhibits ovarian carcinoma cell proliferation
    • Rosanò L, Di Castro V, Spinella F, et al. ZD4054, a potent endothelin receptor A antagonist, inhibits ovarian carcinoma cell proliferation. Exp Biol Med (Maywood). 2006, 231:1132-1135.
    • (2006) Exp Biol Med (Maywood). , vol.231 , pp. 1132-1135
    • Rosanò, L.1    Di Castro, V.2    Spinella, F.3
  • 20
    • 77956190371 scopus 로고    scopus 로고
    • ETAR antagonist ZD4054 exhibits additive effects with aromatase inhibitors and fulvestrant in breast cancer therapy, and improves in vivo efficacy of anastrozole
    • N 27, [Epub ahead of print.]
    • Smollich M, Götte M, Fischgräbe J, et al. ETAR antagonist ZD4054 exhibits additive effects with aromatase inhibitors and fulvestrant in breast cancer therapy, and improves in vivo efficacy of anastrozole. Breast Cancer Res Treat 2009 Nov 27, [Epub ahead of print.].
    • (2009) Breast Cancer Res Treat
    • Smollich, M.1    Götte, M.2    Fischgräbe, J.3
  • 21
    • 59449108669 scopus 로고    scopus 로고
    • Preclinical anticancer activity of the specific endothelin A receptor antagonist ZD4054
    • Growcott JW Preclinical anticancer activity of the specific endothelin A receptor antagonist ZD4054. Anticancer Drugs. 2009, 20:83-88.
    • (2009) Anticancer Drugs. , vol.20 , pp. 83-88
    • Growcott, J.W.1
  • 22
    • 62649134676 scopus 로고    scopus 로고
    • Safety and efficacy of the specific endothelin-A receptor antagonist ZD4054 in patients with hormone-resistant prostate cancer and bone metastases who were pain free or mildly symptomatic: A double-blind, placebo-controlled, randomised, phase 2 trial
    • James ND, Caty A, Borre M, et al. Safety and efficacy of the specific endothelin-A receptor antagonist ZD4054 in patients with hormone-resistant prostate cancer and bone metastases who were pain free or mildly symptomatic: A double-blind, placebo-controlled, randomised, phase 2 trial. Eur Urol. 2009, 55:1112-1123.
    • (2009) Eur Urol. , vol.55 , pp. 1112-1123
    • James, N.D.1    Caty, A.2    Borre, M.3
  • 23
    • 69249209858 scopus 로고    scopus 로고
    • In vitro metabolism of the specific endothelin-A receptor antagonist ZD4054 and clinical drug interactions between ZD4054 and rifampicin or itraconazole in healthy male volunteers
    • Swaisland HC, Oliver SD, Morris T, et al. In vitro metabolism of the specific endothelin-A receptor antagonist ZD4054 and clinical drug interactions between ZD4054 and rifampicin or itraconazole in healthy male volunteers. Xenobiotica. 2009, 39:444-456.
    • (2009) Xenobiotica. , vol.39 , pp. 444-456
    • Swaisland, H.C.1    Oliver, S.D.2    Morris, T.3
  • 24
    • 0032924934 scopus 로고    scopus 로고
    • Cytochrome P-450 3A4: Regulation and role in drug metabolism
    • Guengerich FP Cytochrome P-450 3A4: Regulation and role in drug metabolism. Annu Rev Pharmacol Toxicol. 1999, 39:1-17.
    • (1999) Annu Rev Pharmacol Toxicol. , vol.39 , pp. 1-17
    • Guengerich, F.P.1
  • 28
    • 33846448814 scopus 로고    scopus 로고
    • US Dept of Health and Human Services, Food and Drug Administration (FDA)Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER)Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER)Center for Biologics Evaluation and Research (CBER), Accessed June 29, 2010
    • Guidance for Industry: Drug interaction studies-study design, data analysis, and implications for dosing and labelling US Dept of Health and Human Services, Food and Drug Administration (FDA)Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER)Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER)Center for Biologics Evaluation and Research (CBER), Accessed June 29, 2010. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072101.pdf.
    • Guidance for Industry: Drug interaction studies-study design, data analysis, and implications for dosing and labelling
  • 30
    • 84969255956 scopus 로고
    • WMA Declaration of Helsinki. Ethical principles for medical research involving human subjects
    • J, World Medical Association (WMA), Accessed June 29, 2010
    • WMA Declaration of Helsinki. Ethical principles for medical research involving human subjects. Adopted by the 18th WMA General Assembly, Helsinki, Finland June 1964, World Medical Association (WMA), Accessed June 29, 2010. http://www.wma.net/en/30publications/10policies/b3/index.html.
    • (1964) Adopted by the 18th WMA General Assembly, Helsinki, Finland
  • 34
    • 77955243531 scopus 로고    scopus 로고
    • Relative bioavailability of zibotentan (ZD4054) immediate release tablets compared with a reference oral formulation: A Phase I study in healthy male volunteers
    • Tomkinson HK, Kemp J, Hurewitz S, et al. Relative bioavailability of zibotentan (ZD4054) immediate release tablets compared with a reference oral formulation: A Phase I study in healthy male volunteers. AAPSJ. 2009, 11(Suppl 2):771.
    • (2009) AAPSJ. , vol.11 , Issue.SUPPL 2 , pp. 771
    • Tomkinson, H.K.1    Kemp, J.2    Hurewitz, S.3
  • 35
    • 0030806927 scopus 로고    scopus 로고
    • Midazolam: A review of therapeutic uses and toxicity
    • Nordt SP, Clark RF Midazolam: A review of therapeutic uses and toxicity. J Emerg Med. 1997, 15:357-365.
    • (1997) J Emerg Med. , vol.15 , pp. 357-365
    • Nordt, S.P.1    Clark, R.F.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.