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/day PQP |
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 PQP on the QT/QTc interval compared to AL, placebo and moxifloxacin 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/day PQP |
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 Caucasian volunteers 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/day PQP |
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 after single oral administration of Eurartesim in healthy male adult 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/day PQP |
20 mg DHA/160 mg PQP or 40 mg DHA/320 mg PQP tablet. 3 oral doses in 48 hrs. |
Not Applicable |
32 |
Paediatric P. falciparum malaria patients |
To assess the PK of DHA and PQP by analysing serial blood samples during and after a therapeutic course in children with 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/day PQP |
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 analysing serial blood samples during and after a therapeutic course in 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/day PQP |
20 mg DHA/160 mg PQP or 40 mg DHA/320 mg PQP tablet. 3 oral doses in 48hrs. |
50 mg AS + 250 mg MQ AS 4 mg/kg/day for 3 days + MQ 25 mg/kg divided into two doses |
1150 |
Adult and paediatric P. falciparum malaria patients (even in combination with other Plasmodia) |
To demonstrate that the PCR-corrected cure rate of DHA-PQP at Day 63 is non-inferior to that of AS+MQ (non-inferiority margin=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/day PQP | 20mg DHA/160mg PQP or 40mg DHA/320 mg PQP tablet. 3 oral doses in 48 hrs | 20 mg A/120 mg L 2-6 tablets per day over 3 days dependant on body weight | 1553 | Paediatric P. falciparum malaria patients | To demonstrate that the PCR-corrected cure rate of DHA-PQP at Day 28 is non-inferior to that of AL (non-inferiority margin=5%) | Burkina faso, Kenya, Uganda, Mozambique, Zambia |