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Table 1 Summary of lucerastat and moxifloxacin PK parameters

From: The effect of the glucosylceramide synthase inhibitor lucerastat on cardiac repolarization: results from a thorough QT study in healthy subjects

PK parameter (unit)

Lucerastat

 

2000 mg

4000 mg

n = 6

n = 6

Part A

Cmax (µg/mL)

11.3 (9.9, 13.0)

22.1 (17.6, 27.7)

 

tmax (h)

2.8 (1.5, 4.0)

3.3 (2.5, 4.0)

 

AUC0−t (µg·h/mL)

93.9 (75.7, 116.5)

193.7 (163.8, 229.1)

 

AUC0−∞ (µg·h/mL)

98.1 (79.8, 120.5)

198.8 (167.7, 235.5)

 

t½ (h)

8.0 (5.8, 11.0)

9.3 (7.1, 12.2)

 

PK parameter (unit)

Lucerastat

Moxifloxacin

1000 mg

4000 mg

400 mg

n = 36

n = 36

n = 35

Part B

Cmax (µg/mL)

5.2 (4.9, 5.6)

24.3 (22.8, 26.0)

3.0 (2.7, 3.3)

tmax (h)

2.5 (1.5, 4.0)

2.5 (0.5, 4.0)

2.0 (0.5, 6.0)

AUC0−t (µg·h/mL)

42.1 (39.8, 44.6)

191.1 (183.2, 199.2)

32.6 (30.1, 35.4)

AUC0−∞ (µg·h/mL)

45.0 (42.4, 47.7)

199.3 (190.9, 207.9)

35.9 (33.0, 39.2)

t½ (h)

10.0 (9.1, 11.0)

8.2 (7.6, 8.9)

10.4 (9.7, 11.1)

  1. Data expressed as geometric mean (95% CI) or as median (range) for tmax
  2. AUC0−∞, area under the plasma drug concentration–time curve (from time zero to infinity); AUC0−t, area under the plasma drug concentration–time curve (from time zero to time t of the last measured concentration above the limit of quantification); CI, confidence interval; Cmax, maximum plasma concentration; n, number of subjects with available data; PK, pharmacokinetic; t½, half-life; tmax, time to maximum plasma concentration
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Orphanet Journal of Rare Diseases

ISSN: 1750-1172