TABLE 1.

DP dosing regimens and characteristics of volunteers from three clinical trials conducted between 2010 and 2014 in Anlong Veng, Cambodia

Characteristic	Value(s) for study conducted ina:
	2010	2012	2013
DP dosing regimenb	2DP or 3DP	2DP or placebo	3DP
Patients studied	Patients infected with P. falciparum and P. vivax	Healthy subjects	Patients infected with P. falciparum or mixed P. falciparum and P. vivax and infections
Total no. of evaluable volunteersc	80 (40 receiving 2DP regimen/40 receiving 3DP regimen)	69 (47 receiving 2DP regimen/22 receiving placebo)	107
Median (IQR):
Age (yr)	32 (27–49)	26 (22–56)	25 (21–34)
Wt (kg)	56.2 (34–62)	60.0 (55–65)	56.0 (52–60)
Ht (cm)	163 (160–167)	165 (161–169)	164 (160–168)
Body mass index (kg/m2)	21.2 (20–22)	22.0 (21–24)	20.7 (19–23)
Baseline QTcFm (ms)	400 (383–415)	390 (378–403)	393 (375–410)
Baseline QTcBm (ms)	418 (413–425)	396 (393–402)	412 (411–421)
Maximum QTcFm prolongation (ms)	431 (425–436)	430 (425–440)	430 (427–437)
Maximum QTcBm prolongation (ms)	439 (435–447)	436 (433–447)	439 (436–445)
No. of volunteers with:
ΔQTcFm of >30 ms	40	42 (39/3)d	76
ΔQTcBm of >30 ms	40	26 (22/4)d	43
ΔQTcFm of >60 ms	6	21 (21/0)d	17
ΔQTcBm of >6 0ms	9	7 (5/2)d	11
Median (IQR):
Baseline serum K+ concne (mM)	Not assessed	3.8 (3.7–4.1)	3.6 (3.3–4.0)
Baseline serum Mg2+ concnf (mg/dl)	Not assessed	1.9 (1.8–2.0)	1.8 (1.6–2.0)
Time to previous meal prior to 1st dose (h)	Not assessed	2.9 (1.9–4.5)	2.7 (1.8–4.1)
Avg (IQR) time to previous meal prior to all doses (h)	Not assessed	2.9 (2.0–3.3)	(3.6 (3–4.4)

^aThe studies conducted in 2010 (4), 2012 (3), and 2013 (31) have been described previously.

^bThe total DHA-piperaquine phosphate (DP) dose was 360/2,880 mg.

^cAll volunteers were male, except for 3 females in the study conducted in 2013.

^dData in parentheses represent the number in each category receiving DP/placebo.

^eThe normal K⁺ concentration range is 3.5 to 5.1 mM.

^fThe normal Mg²⁺ concentration range is 1.8 to 2.4 mg/dl.