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Figure 1.

Molecular structure of ST-246.

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Figure 2.

Plots of mean plasma concentration versus time profiles in BALB/c mice following repeat oral administrations of ST-246 by gavage at a dose of 2000 mg/kg for 28 consecutive days.

The adjacent plot represents the corresponding semi-logarithmic plot.

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Figure 2 Expand

Figure 3.

Plots of mean plasma concentration versus time profiles in New Zealand white Hra: (NZW) SPF albino rabbits following repeat oral administrations of ST-246 by gavage at a dose of 100 mg/kg seven consecutive days.

The adjacent plot represents the corresponding semi-logarithmic plot.

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Figure 3 Expand

Figure 4.

Plots of mean plasma concentration versus time profiles in cynomolgus monkeys following repeat oral administrations of ST-246 by gavage at a dose of 100 mg/kg for 28 consecutive days.

The adjacent plot represents the corresponding semi-logarithmic plot.

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Figure 5.

Plots of mean plasma concentration versus time profiles in beagle dogs, following repeat oral administrations of ST-246 by gavage at a dose of 30 mg/kg seven consecutive days.

The adjacent plot represents the corresponding semi-logarithmic plot.

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Table 1.

Plasma pharmacokinetic estimates for BALB/c mice, New Zealand white Hra: (NZW) SPF albino rabbits, beagle dogs and cynomolgus monkeys following repeat oral dosing of ST-246 by gavage for 7 consecutive days in New Zealand white Hra: (NZW) SPF albino rabbits and beagle dogs and 28 consecutive days in BALB/c mice and cynomolgus monkeys.

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Table 1 Expand

Table 2.

Plasma pharmacokinetic estimates for BALB/c mice, New Zealand white Hra: (NZW) SPF albino rabbits, beagle dogs and cynomolgus monkeys following repeat oral dosing of ST-246 by gavage for 7 consecutive days in New Zealand white Hra: (NZW) SPF albino rabbits and beagle dogs and 28 consecutive days in BALB/c mice and cynomolgus monkeys.

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Table 2 Expand

Figure 6.

Linear regression analysis of log-transformed plasma clearance for BALB/c mice, New Zealand white Hra: (NZW) SPF albino rabbits, cynomolgus monkeys and beagle dogs versus log-transformed corresponding animal body weight, following oral administration of ST-246 by gavage at a dose of 2000, 100, 100 and 30 mg/kg, respectively.

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Figure 7.

Linear regression analysis of log-transformed plasma clearance multiplied by corresponding maximum life span potential (MLP) for BALB/c mice, New Zealand white Hra: (NZW) SPF albino rabbits, cynomolgus monkeys and beagle dogs versus log-transformed corresponding animal body weight, following oral administration of ST-246 by gavage at a dose of 2000, 100, 100 and 30 mg/kg, respectively.

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Figure 8.

Linear regression analysis of log- transformed apparent volume of distribution for BALB/c mice, New Zealand white Hra: (NZW) SPF albino rabbits, cynomolgus monkeys and beagle dogs versus log-transformed corresponding animal body weight, following oral (gavage) administration of ST-246 by gavage at a dose of 2000, 100, 100 and 30 mg/kg, respectively.

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Table 3.

Allometric coefficient, allometric exponent and coefficient of determination values from linear regression analysis of pharmacokinetic parameters from BALB/c mice, New Zealand white Hra: (NZW) SPF albino rabbits, cynomolgus monkeys and beagle dogs following repeat oral administration of ST-246 by gavage for 7 consecutive days in New Zealand white Hra: (NZW) SPF albino rabbits and beagle dogs and 28 consecutive days in BALB/c mice and cynomolgus monkeys.

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Table 4.

Observed versus scaled human plasma pharmacokinetics, recommended and given FIH dose levels for ST-246.

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