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Table 6 Simulated % ACPR28 with 90% confidence intervals for single dose combinations of artefenomel and PQP in non-vomiting African children ≤ 5 years old

From: A randomised, double-blind clinical phase II trial of the efficacy, safety, tolerability and pharmacokinetics of a single dose combination treatment with artefenomel and piperaquine in adults and children with uncomplicated Plasmodium falciparum malaria

PQP adult-equivalent dose, mg

 

Artefenomel adult-equivalent dose, mg

 

0

200

400

800

1200

1600

0

NR (–)

22 (14–32)

39 (29–49)

70 (59–79)

86 (78–92)

94 (88–97)

320

27 (18–37)

35 (28–44)

52 (45–59)

79 (73–84)

91 (86–94)

96 (93–98)

640

40 (29–52)

48 (39–58)

64 (58–70)

85 (81–88)

94 (91–96)

97 (95–99)

960

51 (38–64)

59 (48–69)

72 (65–78)

89 (85–92)

95 (93–97)

98 (97–99)

1440

64 (49–76)

70 (59–80)

80 (73–86)

92 (89–95)

97 (95–98)

99 (98–99)

2000

74 (59–85)

79 (67–88)

86 (80–91)

95 (93–97)

98 (97–99)

99 (98–100)

2800

83 (70–91)

86 (76–93)

91 (85–95)

97 (95–98)

99 (98–100)

> 99 (99–100)

3600

88 (78–95)

91 (83–96)

94 (90–97)

98 (96–99)

99 (99–100)

> 99 (99–100)

  1. For the stimulations, the identified age effect on artefenomel PK was not included; it was assumed, therefore, that exposures in the youngest patients were similar to those in the older age groups. NR not reported
  2. Predicted ACPR28 > 95%; outcome predicted with a lower bound > 95%