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Cancer Epidemiology, Biomarkers & Prevention
Cancer Epidemiology, Biomarkers & Prevention
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Phase I Dose Escalation Pharmacokinetic Study in Healthy Volunteers of Resveratrol, a Potential Cancer Chemopreventive Agent

David J. Boocock, Guy E.S. Faust, Ketan R. Patel, Anna M. Schinas, Victoria A. Brown, Murray P. Ducharme, Tristan D. Booth, James A. Crowell, Marjorie Perloff, Andreas J. Gescher, William P. Steward and Dean E. Brenner
David J. Boocock
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Guy E.S. Faust
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Ketan R. Patel
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Anna M. Schinas
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Victoria A. Brown
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Murray P. Ducharme
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Tristan D. Booth
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James A. Crowell
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Marjorie Perloff
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Andreas J. Gescher
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William P. Steward
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Dean E. Brenner
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DOI: 10.1158/1055-9965.EPI-07-0022 Published June 2007
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    Figure 1.

    Structure of resveratrol.

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    Figure 2.

    Mean plasma concentrations of resveratrol (A), two resveratrol monoglucuronides (B and C), and resveratrol-3-sulfate (D) versus time in healthy volunteers who received a single dose of resveratrol at 0.5 (♦), 1 (□), 2.5 (▵), or 5 g (▪). Points, mean of 10 volunteers per dose level. Insets, coefficients of variation.

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    Figure 3.

    Relationship between dose of resveratrol and AUC0-t (A) or Cmax (B) for resveratrol (□), two resveratrol monoglucuronides (♦, ▴), and resveratrol-3-sulfate (▪) in healthy volunteers, who received a single dose of resveratrol at either 0.5, 1, 2.5, or 5 g. Points, mean of 10 volunteers per dose level; bars, SD.

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    Figure 4.

    Excretion of resveratrol (closed columns), two resveratrol monoglucuronides (open and dotted columns), and resveratrol-3-sulfate (striped columns) in the urine of healthy volunteers who received resveratrol. A. Cumulative excretion over 24 h after ingestion of resveratrol at 0.5, 1, 2.5, or 5 g. B. Rate of excretion (per hour) during five collection intervals within 24 h post-administration of 0.5 g resveratrol. Columns, mean of 10 individuals, expressed as percentage of dose; bars, SD.

Tables

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  • Table 1.

    Adverse events in healthy volunteers after a single dose of resveratrol

    Nature of event*No. individuals
    Dose level (g)
    0.51.02.55.0
    Unlikely to be drug related
        Raised urea1010
        Raised creatinine1000
        Low total protein1000
        Raised albumin0001
        Raised phosphate2012
        Low phosphate01†00
        Raised bilirubin0010
        Raised calcium1000
        Raised glucose1311
        Low CO2002‡2
        Raised lactate dehydrogenase1001
        Low lactate dehydrogenase0001
        Raised cholesterol0200
        Low WBC count0010
        Raised neutrophil count0100
        Raised lymphocyte count0100
        Raised eosinophil count0001
        Low basophil count0010
        Raised platelet count1100
        Low hematocrit2000
        Raised chloride1101
        Cellulitic foot infection0100
        Flatulence0100
        Nausea0100
        Loose stool0200
        Panic attack0100
        Headache0110
    Possibly drug related
        Raised bilirubin02‡00
        Raised alanine aminotransferase0100
    • ↵* All (except where indicated) National Cancer Institute Common Toxicity Criteria grade 1.

    • ↵† National Cancer Institute Common Toxicity Criteria grade 2.

    • ↵‡ In one of these two individuals, event was National Cancer Institute Common Toxicity Criteria grade 2.

  • Table 2.

    Pharmacokinetics of resveratrol and three metabolites in the plasma of volunteers after a single oral dose

    VariableDose level (g)
    0.51.02.55.0
    Resveratrol
        AUCinf (ng h/mL)223.7*544.8 (57.2)786.5 (36.2)1,319 (59.1)
        Cmax (ng/mL)72.6 (48.9)117.0 (73.1)268.0 (55.3)538.8 (72.5)
        Tmax (h)0.833 (0.5-1.5)0.759 (0.5-4.0)1.375 (0.5-4.0)1.500 (0.67-5.0)
        Cav (ng/mL)8.36 (57.8)18.04 (51.6)32.25 (43.0)51.90 (80.7)
        Half-life (h)2.85*8.87 (91.1)4.22 (51.6)8.52 (95.8)
        CL/F (L/h)2,235*2,593 (65.1)3,471 (29.9)4,930 (50.0)
        CLR (L/h)1.177 (102.5)0.696 (71.5)0.656 (53.1)1.443 (139.2)
        V/F (liters)9,198*19,298 (54.3)22,226 (67.3)66,991 (112)
    Glucuronide 1
        AUCinf (ng h/mL)1,919 (33.6)3,059 (60.9)5,664 (27.7)9,923 (40.9)
        Cmax (ng/mL)404.6 (35.3)473.6 (76.8)874.4 (37.5)1,285 (55.4)
        Tmax (h)2.00 (1.0-6.0)2.250 (1.0-6.0)2.375 (1.0-8.0)2.00 (1.5-5.0)
        Cav (ng/mL)76.9 (37.2)110.3 (56.1)215.5 (43.5)344.1 (51.5)
        Half-life (h)2.85 (48.6)7.27 (93.9)10.6 (92.9)7.90 (39.1)
        CL/F (L/h)282.7 (27.3)493.5 (74.7)469.5 (25.7)590.6 (45.2)
    Glucuronide 2
        AUCinf (ng h/mL)1,287 (21.7)2,589 (66.4)4,320 (32.9)8,546 (62.3)
        Cmax (ng/mL)369.5 (39.6)672.6 (81.1)1,626 (71.5)1,735 (66.4)
        Tmax (h)1.500 (1.0-5.0)1.750 (1.0-5.1)2.000 (1.0-6.0)2.520 (1.5-8.0)
        Cav (ng/mL)51.0 (27.6)99.9 (66.2)193.8 (39.3)317.8 (65.6)
        Half-life (h)3.09 (69.8)6.64 (92.1)8.42 (88.9)5.83 (51.2)
        CL/F (L/h)408.8 (26.7)642.5 (83.0)636.9 (32.6)1,017 (94.6)
    3-Sulfate
        AUCinf (ng h/mL)4,049 (26.6)10,053 (73.2)16,984 (41.7)30,898 (46.1)
        Cmax (ng/mL)1,135 (25.7)2,102 (81.3)2,786 (27.2)4,294 (48.0)
        Tmax (h)1.500 (1.0-5.0)2.000 (1.0-5.0)2.000 (1.0-5.2)2.050 (1.0-6.0)
        Cav (ng/mL)172.0 (23.2)402.6 (70.5)597.0 (27.0)1,089 (49.4)
        Half-life (h)3.21 (56.6)4.51 (82.8)11.5 (95.5)7.71 (42.3)
        CL/F (L/h)131.2 (25.8)151.8 (62.7)171.2 (40.0)207.8 (63.9)
    • NOTE: Values are the mean of n = 10 with coefficient of variation (in percent) or range in brackets.

      Abbreviations: AUCinf, area under the concentration versus time curve to time infinity; Cmax, maximal plasma concentration; Tmax, median time of maximal plasma concentration; Cav, average plasma concentration; CL/F, apparent total body clearance (calculated as dose/AUCinf); CLR, apparent renal clearance approximated by amount excreted with urine within 24 h over AUC0-24; V/F, apparent volume of distribution.

    • ↵* n = 1, value for AUCinf at the lowest dose could be established in only one participant.

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Cancer Epidemiology Biomarkers & Prevention: 16 (6)
June 2007
Volume 16, Issue 6
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Phase I Dose Escalation Pharmacokinetic Study in Healthy Volunteers of Resveratrol, a Potential Cancer Chemopreventive Agent
David J. Boocock, Guy E.S. Faust, Ketan R. Patel, Anna M. Schinas, Victoria A. Brown, Murray P. Ducharme, Tristan D. Booth, James A. Crowell, Marjorie Perloff, Andreas J. Gescher, William P. Steward and Dean E. Brenner
Cancer Epidemiol Biomarkers Prev June 1 2007 (16) (6) 1246-1252; DOI: 10.1158/1055-9965.EPI-07-0022

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Phase I Dose Escalation Pharmacokinetic Study in Healthy Volunteers of Resveratrol, a Potential Cancer Chemopreventive Agent
David J. Boocock, Guy E.S. Faust, Ketan R. Patel, Anna M. Schinas, Victoria A. Brown, Murray P. Ducharme, Tristan D. Booth, James A. Crowell, Marjorie Perloff, Andreas J. Gescher, William P. Steward and Dean E. Brenner
Cancer Epidemiol Biomarkers Prev June 1 2007 (16) (6) 1246-1252; DOI: 10.1158/1055-9965.EPI-07-0022
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