Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03660839 | Study to Investigate the Clinical and Parasiticidal Activity and Pharmacokinetics of Different Doses of Artefenomel and Ferroquine in Patients With Uncomplicated Plasmodium Falciparum Malaria | PHASE2 | COMPLETED | 140 | — | — | Sep 11, 2018 | Nov 6, 2019 | Mar 21, 2022 | 7 | Benin, Burkina Faso +3 |
ACPR:absence of parasitemia at Day 28, irrespective of axillary temperature(AT), participants not meeting any criteria of early therapy failure(ETF):Danger signs(DS)/symptoms of complicated(SoC)/severe malaria(SM) at Day 1, 2 or 3 in presence of parasitemia, concomitant to at least 1 positive parasitemia;or parasitemia on Day 2 \>Day 0 irrespective of AT;or parasitemia on Day 3 with AT\>=37.5 degree Celsius (°C);or parasitemia count on Day 3 \>=25 percent (%) on Day 0, or late clinical failure (LCF):DS/SM in presence of parasitemia between Day 4 and 28,concomitant to at least one positive parasitemia;or presence of parasitemia and AT\>=37.5°C on Day 4 to Day 28, or late parasitological failure(LPF):presence of parasitemia between Day 7 and 28 and AT\<37.5°C and without rescue therapy. PCR-corrected ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with genotype identical to that present at Baseline), excluding participants with reinfection.
| Arm | Type | Description |
|---|---|---|
| Ferroquine 400 milligram (mg) | EXPERIMENTAL | On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition. |
| Ferroquine 400 mg + Artefenomel 300 mg | EXPERIMENTAL | On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 300 mg oral suspension. |
| Ferroquine 400 mg + Artefenomel 600 mg | EXPERIMENTAL | On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 600 mg oral suspension. |
| Ferroquine 400 mg + Artefenomel 1000 mg | EXPERIMENTAL | On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 1000 mg oral suspension. |
| Name | Type | Description |
|---|---|---|
| Artefenomel (OZ439) | DRUG | Pharmaceutical form: Granules for oral suspension Route of administration: Oral |
| Ferroquine (SSR97193) | DRUG | Pharmaceutical form: Capsule Route of administration: Oral |
Inclusion criteria : Participants (14-69 years old inclusive) with body weight within 35 and 90 kilograms (kg), with uncomplicated Plasmodium falciparum (P. falciparum) malaria, with a fever as defined with axillary temperature greater than or equal to (\>=) 37.5 degree Celsius (°C) or oral/ rectal...