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First-in-human clinical trial to assess the safety, tolerability and pharmacokinetics of P218, a novel candidate for malaria chemoprotection.
Chughlay MF, Rossignol E, Donini C, El Gaaloul M, Lorch U, Coates S, Langdon G, Hammond T, Möhrle J, Chalon S. Chughlay MF, et al. Among authors: el gaaloul m. Br J Clin Pharmacol. 2020 Jun;86(6):1113-1124. doi: 10.1111/bcp.14219. Epub 2020 Feb 12. Br J Clin Pharmacol. 2020. PMID: 31925817 Free PMC article. Clinical Trial.
Chemoprotective Antimalarial Activity of P218 against Plasmodium falciparum: A Randomized, Placebo-Controlled Volunteer Infection Study.
Chughlay MF, El Gaaloul M, Donini C, Campo B, Berghmans PJ, Lucardie A, Marx MW, Cherkaoui-Rbati MH, Langdon G, Angulo-Barturen I, Viera S, Rosanas-Urgell A, Van Geertruyden JP, Chalon S. Chughlay MF, et al. Among authors: el gaaloul m. Am J Trop Med Hyg. 2021 Feb 8;104(4):1348-58. doi: 10.4269/ajtmh.20-1165. Online ahead of print. Am J Trop Med Hyg. 2021. PMID: 33556040 Free PMC article.
Optimizing Pharmacology Studies in Pregnant and Lactating Women Using Lessons From HIV: A Consensus Statement.
Eke AC, Olagunju A, Momper J, Penazzato M, Abrams EJ, Best BM, Capparelli EV, Bekker A, Belew Y, Kiser JJ, Struble K, Taylor G, Waitt C, Mirochnick M, Cressey TR, Colbers A; participants of the WHO-IMPAACT workshop on “Approaches to Optimize and Accelerate Pharmacokinetic Studies in Pregnant and Lactating Women”. Eke AC, et al. Clin Pharmacol Ther. 2021 Jul;110(1):36-48. doi: 10.1002/cpt.2048. Epub 2020 Oct 15. Clin Pharmacol Ther. 2021. PMID: 32930408 Free PMC article.
A randomised, double-blind clinical phase II trial of the efficacy, safety, tolerability and pharmacokinetics of a single dose combination treatment with artefenomel and piperaquine in adults and children with uncomplicated Plasmodium falciparum malaria.
Macintyre F, Adoke Y, Tiono AB, Duong TT, Mombo-Ngoma G, Bouyou-Akotet M, Tinto H, Bassat Q, Issifou S, Adamy M, Demarest H, Duparc S, Leroy D, Laurijssens BE, Biguenet S, Kibuuka A, Tshefu AK, Smith M, Foster C, Leipoldt I, Kremsner PG, Phuc BQ, Ouedraogo A, Ramharter M; OZ-Piperaquine Study Group. Macintyre F, et al. BMC Med. 2017 Oct 9;15(1):181. doi: 10.1186/s12916-017-0940-3. BMC Med. 2017. PMID: 28988541 Free PMC article. Clinical Trial.