Table 1 Studies of Eurartesim in patients
Study | Dose | Test regimen | Comparator | Total no. of subjects | Subject type | Main efficacy endpoint | Countries |
|---|---|---|---|---|---|---|---|
ST3073+ST3074 DM09006 Phase I | Dose range: 1.6-2.5 mg/kg/day DHA and 12.4-20.3 mg/kg/dayPQP | 40 mg DHA/320 mg PQP tablet. 3 oral doses in 48 hrs. | Placebo, Riamet,(AL), moxifloxacin | 268 | Adult healthy volunteers | To evaluate the effect of multiple oral doses of DHA and PQPon the QT/QTc interval compared to AL, placebo andmoxifloxacin in healthy male and female volunteers | France |
ST3073+ST3074 DM09007 Phase I | Dose range: 1.6-2.7 mg/kg/day DHA and 12.4-21.8 mg/kg/dayPQP | 40 mg DHA/320 mg PQP tablet. 3 oral doses in 48 hrs. | Not Applicable | 72 | Adult healthy volunteers | DHA and PQP PK in healthy male and female Asian and Caucasianvolunteers after single and repeated dose of Eurartesim | Australia |
ST3073+ST3074 DM09008 Phase I | Dose range: 1.7-2.1 mg/kg/day DHA and 13.9-17 mg/kg/dayPQP | 40 mg DHA/320 mg PQP tablet. One single oral dose. | Not Applicable | 37 | Adult healthy volunteers | To assess the effect of food on the PK of DHA and PQP aftersingle oral administration of Eurartesim in healthy maleadult volunteers | Australia |
ST3073+ST3074 DM 04008 (Africa) Phase I/II | Dose range: 1.67-3.08 mg/kg/day DHA and 13.3-24.64 mg/kg/dayPQP | 20 mg DHA/160 mg PQP or 40 mg DHA/320 mg PQP tablet. 3 oraldoses in 48 hrs. | Not Applicable | 32 | Paediatric P. falciparum malaria patients | To assess the PK of DHA and PQP by analysing serial bloodsamples during and after a therapeutic course in childrenwith malaria | Burkina Faso |
ST3073+ST3074 DM04009 (Asia) Phase I/II | Dose range: 1.6-3.64 mg/kg/day DHA and 12.8-29.12 mg/kg/dayPQP | 40 mg DHA/320 mg PQP tablet. 3 oral doses in 48 hrs. | Not Applicable | 25 | Adult P. falciparum malaria patients | To assess the pharmacokinetics of DHA and PQP by analysingserial blood samples during and after a therapeutic coursein adults with malaria. | Thailand |
ST3073+ST3074 DM040010 (Asia) Phase III | Dose range:1.67-3.33 mg/kg/day DHA and 13.3-26.7 mg/kg/dayPQP | 20 mg DHA/160 mg PQP or 40 mg DHA/320 mg PQP tablet. 3 oraldoses in 48hrs. | 50 mg AS + 250 mg MQ AS 4 mg/kg/day for 3 days + MQ 25 mg/kgdivided into two doses | 1150 | Adult and paediatric P. falciparum malariapatients (even in combination with other Plasmodia) | To demonstrate that the PCR-corrected cure rate of DHA-PQP atDay 63 is non-inferior to that of AS+MQ (non-inferioritymargin=5%) | Thailand, India, Laos |
ST3073+ST3074 DM040011 (Africa) Phase III | Dose range: 1.6-3.64 mg/kg/day DHA and 12.8-29.12 mg/kg/dayPQP | 20mg DHA/160mg PQP or 40mg DHA/320 mg PQP tablet. 3 oraldoses in 48 hrs | 20 mg A/120 mg L 2-6 tablets per day over 3 days dependant onbody weight | 1553 | Paediatric P. falciparum malaria patients | To demonstrate that the PCR-corrected cure rate of DHA-PQP atDay 28 is non-inferior to that of AL (non-inferioritymargin=5%) | Burkina faso, Kenya, Uganda, Mozambique, Zambia |