Table 2 Mean values (±s.d.) of plasma pharmacokinetic parameters and % excreted in urine at various SR4554 dose levels

From: A phase I study of the nitroimidazole hypoxia marker SR4554 using 19F magnetic resonance spectroscopy

Dose level (mg m−2)

No. of patients

T max (h)

Cmax (mg l−1)

AUClast (h*mg l−1)

T 1/2 (h)

V ss (l)

Cl (l h−1)

% excreted

1400

15

0.9±0.3

98±49a

310±160a

3.8±0.9

37±17

10.5±4.7b

58.6±4.9

1800

1

1.0

74

308

3.1

45

12.7

43

2200

1

1.2

85

291

3.2

38

12.7

35

2600

8

1.0±0.1

141±49a

641±231a

3.7±1.0

27±6

7.7±2.7b

37.3±5.9

  1. Abbreviation: AUC=area under the curve.
  2. a Comparison of patients treated at dose levels 1400 and 2600 mg m−2 showed significant correlation both between dose level and AUC (P=0.0006), and between dose level and Cmax (P=0.05; unpaired Student's t-test, two-sided). Patients treated at the intermediate dose levels of 1800 and 2200 mg m−2 were not included in this analysis as only one patient was treated at each of these dose levels.
  3. b No statistically significant difference in plasma clearance was observed between the 1400 and 2600 mg m−2 groups of patients (P=0.14; unpaired Student's t-test, two-sided).
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