10 completed, 3 terminated. 9 Phase 1, 5 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 9 | Completed 7, Terminated 2 |
| Phase 2 | 5 | Completed 3, Terminated 2 |
| Phase 3 | 1 | Completed 1 |
Follow artefenomel: new trials by email Literature Review of artefenomel trials Research Report on artefenomel
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study to Investigate the Clinical and Parasiticidal Activity and Pharmacokinetics of Different Doses of Artefenomel and Ferroquine in Patients With Uncomplicated Plasmodium Falciparum Malaria Artefenomel (OZ439), Ferroquine (SSR97193) - Plasmodium Falciparum Infection | Phase 2 | Completed | Sanofi | 140 | 2018-09-11 | 2022-03-21 |
| Safety, Tolerability and Antimalarial Activity of Single Doses of OZ439 and PQP 480 mg Piperaquine phosphate, 640 mg Piperaquine phosphate, 200 mg OZ 439 - Malaria | Phase 1 | Completed | Medicines for Malaria Venture | 24 | 2018-04-23 | 2024-05-10 |
| Absolute BA and OZ439 PK Effect of Different OZ439 Dose Volumes and Cobicistat Co-administration Study Single oral dose of 800 mg OZ439, Single oral dose of 400 mg OZ439, Single oral dose of cobicistat - Malaria | Phase 1 | Completed | Medicines for Malaria Venture | 26 | 2017-02-28 | 2019-11-26 |
| A Study to Characterise the Antimalarial and Transmission Blocking Activity of a Single Dose of DSM265 or OZ439 in Healthy Subjects With Induced Blood Stage Plasmodium Falciparum or Plasmodium Vivax Infection DSM265, OZ439 - Malaria | Phase 1 / Phase 2 | Terminated | Medicines for Malaria Venture | 16 | 2015-10-01 | 2020-06-05 |
| To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine and Artefenomel in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria Ferroquine SSR97193, Artefenomel, Placebo - Plasmodium Falciparum Infection | Phase 2 | Terminated | Sanofi | 377 | 2015-07-25 | 2022-03-24 |
| Bioavailability Study of Oral OZ439 Prototype Granule Formulations Administered With Piperaquine Phosphate (PQP) Tablets OZ439 + TPGS, OZ439 Prototype 1, OZ439 Prototype 3 - Malaria | Phase 1 | Completed | Medicines for Malaria Venture | 48 | 2015-04-01 | 2016-02-08 |
| Phase II Efficacy Study of Artefenomel & Piperaquine in Adults & Children With P. Falciparum Malaria. Artefenomel 800mg: piperaquine 640mg, Artefenomel 800mg: piperaquine 960mg, Artefenomel 800mg: piperaquine 1440mg - Uncomplicated Plasmodium Falciparum Malaria | Phase 2 / Phase 3 | Completed | Medicines for Malaria Venture | 448 | 2014-07-01 | 2017-03-10 |
| Open Label Pharmacokinetic Study of OZ439 and Piperaquine on Administration of OZ439+TPGS Granules for Oral Suspension Alone or With Either Piperaquine Phosphate Tablets or Granules for Oral Solution in Healthy Volunteers 1440mg PQP tablets, 960mg PQP tablets, 800mg OZ439 + TPGS - Malaria | Phase 1 | Completed | Medicines for Malaria Venture | 55 | 2013-10-01 | 2015-05-08 |
| A Comparison of the Bioavailability of OZ439 When Delivered Directly to the Small Intestine, or Via the Oral Route OZ439 120mg PIB, 120 mg OZ439 caplet, 120mg OZ439 caplet via Enterion capsule - Healthy Volunteers | Phase 1 | Completed | Medicines for Malaria Venture | 11 | 2012-11-01 | 2015-03-06 |
| Safety, Tolerability & Pharmacokinetics (PK) of Co-administered Single Doses of OZ439 and Mefloquine (MQ) in Healthy Volunteers OZ439 100mg, OZ439 400mg, MQ 250 mg, single dose - Malaria | Phase 1 | Terminated | Medicines for Malaria Venture | 25 | 2012-08-01 | 2015-04-16 |
| Study To Investigate The Relative Bioavailability of OZ439 Formulations In Healthy Volunteers OZ439 mesylate 800mg Powder in Bottle for Oral Suspension, OZ439 mesylate 400mg Prototype Solution Formula 1, OZ439 mesylate 800mg Prototype Solution Formula 1 - Healthy Volunteers | Phase 1 | Completed | Medicines for Malaria Venture | 52 | 2012-04-01 | 2015-01-29 |
| Efficacy, Tolerability, PK of OZ439 in Adults With Acute, Uncomplicated P.Falciparum or Vivax Malaria Mono-infection OZ439 - Malaria, Falciparum, Malaria, Vivax | Phase 2 | Completed | Medicines for Malaria Venture | 82 | 2010-10-01 | 2014-12-03 |
| A Study to Investigate the Safety, Tolerability and Pharmacokinetics of OZ439 in Healthy Male and Female Subjects OZ439 50mg API capsules, OZ439 200mg API capsules, OZ439 400mg aqueous dispersion - Malaria Falciparum, Malaria Vivax | Phase 1 | Completed | Medicines for Malaria Venture | 63 | 2009-04-01 | 2015-01-08 |
Malaria (7) · Malaria, Falciparum (3) · Malaria, Vivax (2)
Medicines for Malaria Venture (11) · Sanofi (2)
Australia (3) · Benin (3) · Burkina Faso (3) · Gabon (3) · Uganda (3) · United Kingdom (3) · Kenya (2) · Mozambique (2) · Vietnam (2) · Democratic Republic of the Congo (1) · Netherlands (1) · South Africa (1) · United States (1)
Fiona Macintyre, PhD (3) · James McCarthy, Prof (1) · Joerg Moehrle, PhD (1) · Karen I Barnes (1) · Maria Gutierrez, MD (1) · Michael Ramharter, MD (1) · Peter Peter Hodsman, MD (1) · Rebecca Webster, Dr (1) · Sasithon Pukrittayakamee, MD (1) · Ulrike Lorch, MD FRCA FFPM (1)
PMID 22759078, PMID 26448141, PMID 28988541, PMID 30858218, PMID 30967148, PMID 32479608, PMID 34011358, PMID 34179977, PMID 36597076, PMID 39609822