Favorite Datasets from Early Phases of Drug Research

Single Rising Dose Pharmacokinetic Study

Part 6 - Table 4


Thirty two healthy male subjects (Sub) entered a double-blind, placebo-controlled, single rising dose study of Drug P. There were four panels of eight subjects. In each panel, subjects were randomized to one of four sequences of increasing doses of Drug P and placebo. For example, in Panel 1 two subjects received placebo, 10mg, 20mg, 40mg; two subjects received 10mg, placebo, 20mg, 40mg; two subjects received 10 mg, 20mg, placebo, 40mg, and two subjects received 10mg, 20mg, 40mg, and placebo. A one week washout period separated the treatments. Panel 2 (40mg, 80mg, 120mg, placebo), Panel 3 (120mg, 150mg, 200mg, placebo), and Panel 4 (200mg, 250mg, 300mg, placebo) followed Panel 1 in order.

Plasma samples were taken from each subject for each treatment at specified time points both pre and post dose, from which area-under-the-plasma-concentration-vs.-time curve, AUC (ng·hr/mL), and maximum plasma concentration, Cmax (ng/mL), were calculated for both the parent (P) compound, Drug P, and its metabolite (M).

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Part 6 - Table 4
Single Rising Dose Pharmacokinetic Study

 

 

 

 

AUC

Cmax

Panel

Sub

Cpd

10mg

20mg

40mg

10mg

20mg

40mg

 

 

 

 

 

 

 

 

 

1

1

P

91.5

217.8

330.7

42.4

82.0

241.3

 

 

M

395.6

728.3

2170.2

39.6

70.0

310.5

 

2

P

96.6

82.1

705.0

29.2

68.9

202.8

 

 

M

714.1

630.7

1728.5

25.4

47.1

197.0

 

3

P

NA

146.4

266.9

30.2

124.3

117.0

 

 

M

334.2

856.4

1650.7

45.3

113.7

248.1

 

4

P

NA

84.4

140.4

NA

105.8

103.2

 

 

M

370.8

707.7

982.3

30.0

70.9

117.8

 

5

P

NA

NA

NA

NA

NA

NA

 

 

M

NA

NA

NA

NA

NA

NA

 

6

P

NA

116.7

229.8

NA

25.2

74.4

 

 

M

NA

NA

NA

NA

NA

NA

 

7

P

NA

215.1

426.2

25.5

52.1

139.9

 

 

M

571.1

978.0

1863.6

45.2

85.1

247.9

 

8

P

NA

102.2

312.8

20.2

43.0

127.6

 

 

M

220.0

766.4

1664.0

26.6

78.0

266.2

 

 

 

 

 

 

 

 

 

 

 

 

40mg

80mg

120mg

40mg

80mg

120mg

 

 

 

 

 

 

 

 

 

2

9

P

378.2

901.7

1329.9

171.7

809.3

682.4

 

 

M

2211.9

5144.7

8151.4

204.4

702.8

1222.8

 

10

P

362.8

923.7

NA

239.5

498.4

NA

 

 

M

1354.8

2865.2

NA

128.8

327.3

NA

 

11

P

353.9

778.4

996.0

197.0

372.2

710.3

 

 

M

1897.7

3336.0

4594.0

210.5

516.9

945.8

 

12

P

255.1

649.6

1123.4

326.0

477.0

947.0

 

 

M

1797.0

4183.2

6340.9

178.3

586.5

1032.8

 

13

P

526.1

927.6

1566.1

379.9

454.1

1288.7

 

 

M

940.5

1883.3

2857.9

110.0

228.1

493.7

 

14

P

1036.7

2115.5

2948.1

541.2

922.3

1758.7

 

 

M

2828.3

6153.9

8323.7

269.7

715.3

1094.2

 

15

P

359.5

845.3

1203.0

234.5

539.5

759.7

 

 

M

1855.1

3318.4

4512.2

199.2

445.8

875.2

 

16

P

188.2

319.9

537.6

125.4

226.8

392.8

 

 

M

1146.8

2229.3

3307.6

112.4

322.0

652.1

 

 

 

 

 

 

 

 

 

 

 

 

120mg

150mg

200mg

120mg

150mg

200mg

 

 

 

 

 

 

 

 

 

3

17

P

1323.2

2076.8

2917.6

828.4

1195.8

2213.6

 

 

M

5486.3

9339.0

10953.6

695.2

1263.2

1730.0

 

18

P

1648.4

1726.3

2344.0

1098.3

1139.9

2049.8

 

 

M

6349.5

7908.5

9703.9

1074.1

1376.3

1890.9

 

19

P

1709.6

1829.0

3245.5

1299.2

1117.5

2447.4

 

 

M

5515.3

5776.8

7694.9

921.6

895.9

1224.1

 

20

P

649.8

1343.8

2040.0

401.6

1053.8

2124.9

 

 

M

4645.0

6782.7

7080.4

934.2

1338.2

1863.0

 

21

P

871.0

1674.7

2370.3

562.8

1681.7

2526.9

 

 

M

3450.0

4684.1

5842.8

771.3

1113.4

1309.9

 

22

P

1289.0

1562.6

2462.8

900.7

661.6

1925.6

 

 

M

6803.3

8677.2

11885.2

967.9

1412.8

2406.2

 

23

P

948.2

1220.9

2091.1

548.0

694.4

2760.9

 

 

M

3926.1

4727.5

6029.7

740.1

953.3

1674.9

 

24

P

1022.1

1990.2

2730.7

819.2

1583.7

1217.0

 

 

M

5742.9

6559.2

8146.4

1194.8

1579.6

1601.4

 

 

 

 

 

 

 

 

 

 

 

 

200mg

250mg

300mg

200mg

250mg

300mg

 

 

 

 

 

 

 

 

 

4

25

P

2358.6

2688.1

3459.6

1627.8

1711.7

2407.8

 

 

M

11114.6

12873.2

15159.7

2856.0

3062.9

2941.7

 

26

P

1913.3

1990.2

1961.0

2034.6

945.4

892.2

 

 

M

6910.2

6270.3

6688.4

1233.4

1242.4

1281.2

 

27

P

3753.1

3934.5

4449.5

4398.4

4625.8

4648.2

 

 

M

9932.1

12219.3

11192.6

1693.8

2213.8

2413.2

 

28

P

3066.3

3966.3

6527.5

2717.2

3366.3

5420.5

 

 

M

7512.8

9354.6

13069.9

1984.9

2400.4

3012.7

 

29

P

1803.3

2469.5

3268.2

2364.6

2360.4

3240.6

 

 

M

7657.6

10173.0

12212.7

1622.3

2304.4

2895.6

 

30

P

NA

NA

NA

NA

NA

NA

 

 

M

NA

NA

NA

NA

NA

NA

 

31

P

1412.2

1724.5

2769.7

1468.5

1161.0

1902.6

 

 

M

5219.3

5391.6

7108.8

1232.2

1442.3

1920.9

 

32

P

1065.2

1198.2

2011.2

782.7

660.5

1580.4

 

 

M

6094.8

7122.5

8394.4

1454.6

1613.1

1824.7


Source

Bradstreet, T. E. and Short, T. H. (2006) "Favorite Data Sets from Early Phases of Drug Research - Part 6." Proceedings of the Section on Statistical Education of the American Statistical Association.

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Last modified September 4, 2011 - THS