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

Summary

Part A -Cohort 1 DSM265 will be administered as a single dose (400 mg). For cohort 1 only, an additional single dose (400 mg) of DSM265 may be given if gametocytemia develops. Treatment with DSM265 will be given after an overnight fasting period of ≥ 8 hours. If dosing is to occur in the evening, subjects will be required to fast for ≥4 hours prior to receiving treatment. Subjects will be required to fast for a further four hours anytime after dosing with DSM265. Part B * Cohort 2 OZ439 will be administered as a single 200 mg dose. If recrudescence is observed, a single 400 mg dose of OZ439 will be given. Treatment with OZ439 will be administered after an overnight fasting period of ≥ 6 hours. If dosing is to occur in the evening, subjects will be required to fast for ≥4 hours prior to receiving treatment. Participants will drink 200 mL of milk prior to drug administration, and then swallow the appropriate volume of OZ439 suspension. Subjects will be required to fast for a further six hours anytime after dosing with OZ439. * Cohort 3 DSM265 will be administered as a single dose (400 mg) as described for cohort 1. No additional dose will be administered.

Timeline

Start

2015-10

Primary completion

2016-05

Completion

2016-05

Publications

• Dini S, Zaloumis SG, Price DJ, Gobeau N, Kummel A, Cherkaoui M, Moehrle JJ, McCarthy JS, Simpson JA. Seeking an optimal dosing regimen for OZ439/DSM265 combination therapy for treating uncomplicated falciparum malaria. J Antimicrob Chemother. 2021 Aug 12;76(9):2325-2334. doi: 10.1093/jac/dkab181.
• Collins KA, Abd-Rahman AN, Marquart L, Ballard E, Gobeau N, Griffin P, Chalon S, Mohrle JJ, McCarthy JS. Antimalarial Activity of Artefenomel Against Asexual Parasites and Transmissible Gametocytes During Experimental Blood-Stage Plasmodium vivax Infection. J Infect Dis. 2022 Mar 15;225(6):1062-1069. doi: 10.1093/infdis/jiaa287.
• Collins KA, Ruckle T, Elliott S, Marquart L, Ballard E, Chalon S, Griffin P, Mohrle JJ, McCarthy JS. DSM265 at 400 Milligrams Clears Asexual Stage Parasites but Not Mature Gametocytes from the Blood of Healthy Subjects Experimentally Infected with Plasmodium falciparum. Antimicrob Agents Chemother. 2019 Mar 27;63(4):e01837-18. doi: 10.1128/AAC.01837-18. Print 2019 Apr.

Drugs

Indications