المؤلفون: Azrin N. Abd-Rahman, Daniel Kaschek, Anne Kümmel, Rebecca Webster, Adam J. Potter, Anand Odedra, Stephen D. Woolley, Stacey Llewellyn, Lachlan Webb, Louise Marquart, Stephan Chalon, Myriam El Gaaloul, James S. McCarthy, Jörg J. Möhrle, Bridget E. Barber

المصدر: BMC Medicine, Vol 22, Iss 1, Pp 1-14 (2024)

مصطلحات موضوعية: Artefenomel, Piperaquine, Antimalarial, Combination, Volunteer infection study, Pharmacokinetics, Medicine

وصف الملف: electronic resource

Relation: https://doaj.org/toc/1741-7015

URL الوصول: https://doaj.org/article/1ad787d5bda644748f24b01ed0c73bbd

المؤلفون: QIMR Berghofer Medical Research Institute, Clinical Network Services (CNS) Pty Ltd, Q-Pharm Pty Limited

المصدر: Phase 1b to Assess Safety, Tolerability, Pharmacokinetic Profile, and Antimalarial Activity of Single Doses of Co-administered OZ439and PQP Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Adult Volunteers

المؤلفون: Rimmy Nandal, Davinder Kumar, Navidha Aggarwal, Virender Kumar, Balasubramanian Narasimhan, Rakesh Kumar Marwaha, Prabodh Chander Sharma, Surender Kumar, Nitin Bansal, Hitesh Chopra, Aakash Deep

المصدر: EXCLI Journal : Experimental and Clinical Sciences, Vol 23, Pp 672-713 (2024)

مصطلحات موضوعية: antimalarials, clinical trials, malaria, tafenoquine, cipargamin, artefenomel, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282, Biology (General), QH301-705.5

وصف الملف: electronic resource

Relation: https://www.excli.de/excli/article/view/6856; https://doaj.org/toc/1611-2156

URL الوصول: https://doaj.org/article/202fcb5419494dc49082aaec1efb65a6

المؤلفون: Medicines for Malaria Venture

المصدر: A Randomized, Double-blind, Phase IIb Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine (FQ) With Artefenomel (OZ439) in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria
Adoke Y, Zoleko-Manego R, Ouoba S, Tiono AB, Kaguthi G, Bonzela JE, Duong TT, Nahum A, Bouyou-Akotet M, Ogutu B, Ouedraogo A, Macintyre F, Jessel A, Laurijssens B, Cherkaoui-Rbati MH, Cantalloube C, Marrast AC, Bejuit R, White D, Wells TNC, Wartha F, Leroy D, Kibuuka A, Mombo-Ngoma G, Ouattara D, Mugenya I, Phuc BQ, Bohissou F, Mawili-Mboumba DP, Olewe F, Soulama I, Tinto H; FALCI Study Group. A randomized, double-blind, phase 2b study to investigate the efficacy, safety, tolerability and pharmacokinetics of a single-dose regimen of ferroquine with artefenomel in adults and children with uncomplicated Plasmodium falciparum malaria. Malar J. 2021 May 19;20(1):222. doi: 10.1186/s12936-021-03749-4.

المؤلفون: Medicines for Malaria Venture

المصدر: A Randomized, Open Label, Parallel-group, Single Dose Regimen, Phase 2a Study, to Investigate the Clinical and Parasiticidal Activity and the Pharmacokinetics of 3 Dose Levels of Artefenomel (OZ439) Given in Combination With Ferroquine (FQ) and FQ Alone, in African Patients With Uncomplicated Plasmodium Falciparum Malaria

المؤلفون: Nandal, Rimmy, Kumar, Davinder, Aggarwal, Navidha, Kumar, Virender, Narasimhan, Balasubramanian, Marwaha, Rakesh Kumar, Sharma, Prabodh Chander, Kumar, Surender, Bansal, Nitin, Chopra, Hitesh, Deep, Aakash

المصدر: EXCLI Journal; Bd. 23 (2024); 672-713 ; EXCLI Journal; Vol. 23 (2024); 672-713 ; 1611-2156

مصطلحات موضوعية: antimalarials, clinical trials, malaria, tafenoquine, cipargamin, artefenomel

وصف الملف: application/pdf

Relation: https://www.excli.de/excli/article/view/6856/4933; https://www.excli.de/excli/article/view/6856/4979; https://www.excli.de/excli/article/view/6856/4980; https://www.excli.de/excli/article/view/6856

الاتاحة: https://www.excli.de/excli/article/view/6856

المؤلفون: Adama Gansane, Moussa Lingani, Adoke Yeka, Alain Nahum, Marielle Bouyou-Akotet, Ghyslain Mombo-Ngoma, Grace Kaguthi, Catalina Barceló, Bart Laurijssens, Cathy Cantalloube, Fiona Macintyre, Elhadj Djeriou, Andreas Jessel, Raphaël Bejuit, Helen Demarest, Anne Claire Marrast, Siaka Debe, Halidou Tinto, Afizi Kibuuka, Diolinda Nahum, Denise Patricia Mawili-Mboumba, Rella Zoleko-Manego, Irene Mugenya, Frederick Olewe, Stephan Duparc, Bernhards Ogutu

المصدر: Malaria Journal, Vol 22, Iss 1, Pp 1-16 (2023)

مصطلحات موضوعية: Artefenomel, Ferroquine, Combination treatment, Uncomplicated P. falciparum malaria, Clinical trial, Exposure–response, Arctic medicine. Tropical medicine, RC955-962, Infectious and parasitic diseases, RC109-216

وصف الملف: electronic resource

Relation: https://doaj.org/toc/1475-2875

URL الوصول: https://doaj.org/article/f65785a4b7b84297a418e877222c7d6a

المؤلفون: Clinical Network Services (CNS) Pty Ltd, Q-Pharm Pty Limited, Queensland Institute of Medical Research

المصدر: A Phase Ib 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
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.

المصدر: Evaluation of the Effect of Artemisinin-based Combination Therapies on Urinary Schistosoma Haematobium When Administered for the Treatment of Malaria Co-infection
Zoleko-Manego R, Okwu DG, Handrich C, Dimessa-Mbadinga LB, Akinosho MA, Ndzebe-Ndoumba WF, Davi SD, Stelzl D, Veletzky L, Kreidenweiss A, Nordmann T, Adegnika AA, Lell B, Kremsner PG, Ramharter M, Mombo-Ngoma G. Effectiveness of antimalarial drug combinations in treating concomitant urogenital schistosomiasis in malaria patients in Lambarene, Gabon: A non-randomised event-monitoring study. PLoS Negl Trop Dis. 2022 Oct 31;16(10):e0010899. doi: 10.1371/journal.pntd.0010899. eCollection 2022 Oct.

المصدر: An Open-label, Two-part Study to Determine the Absolute Bioavailability (BA) of OZ439 Using Simultaneous Intravenous [14C]-OZ439 Microdose/800mg Oral Dosing and to Investigate the Pharmacokinetics (PK) of OZ439 Granules Administered as Single Doses Suspended in Different Volumes and When Co-administered With a Single Dose of Cobicistat, a Strong CYP3A4 Inhibitor, to Healthy Subjects in Fasted State

المصدر: The Extended Observation Over a Period of 28 Days of the Effects of Single Doses of OZ439 on the Recrudescence of Plasmodium Falciparum Malaria - a PhIIa, Open Label Study in Adult Patients
Vennerstrom JL, Arbe-Barnes S, Brun R, Charman SA, Chiu FC, Chollet J, Dong Y, Dorn A, Hunziker D, Matile H, McIntosh K, Padmanilayam M, Santo Tomas J, Scheurer C, Scorneaux B, Tang Y, Urwyler H, Wittlin S, Charman WN. Identification of an antimalarial synthetic trioxolane drug development candidate. Nature. 2004 Aug 19;430(7002):900-4. doi: 10.1038/nature02779.

المصدر: Randomised Phase IIb Study of Efficacy, Safety, Tolerability & Pharmacokinetics of a Single Dose Regimen of Artefenomel (OZ439) in Loose Combination With Piperaquine in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria.
Leroy D, Macintyre F, Adoke Y, Ouoba S, Barry A, Mombo-Ngoma G, Ndong Ngomo JM, Varo R, Dossou Y, Tshefu AK, Duong TT, Phuc BQ, Laurijssens B, Klopper R, Khim N, Legrand E, Menard D. African isolates show a high proportion of multiple copies of the Plasmodium falciparum plasmepsin-2 gene, a piperaquine resistance marker. Malar J. 2019 Apr 10;18(1):126. doi: 10.1186/s12936-019-2756-4.
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. 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. BMC Med. 2017 Oct 9;15(1):181. doi: 10.1186/s12916-017-0940-3.

المؤلفون: Quotient Clinical

المصدر: A Phase I Bioavailability Study of Selected Oral Prototype Granule Formulations of OZ439 in Healthy Subjects, to Evaluate the Pharmacokinetics of OZ439 When Co-Administered With Piperaquine Phosphate Tablets in the Fasted State

المؤلفون: Q-Pharm Pty Limited, QIMR Berghofer Medical Research Institute, Clinical Network Services (CNS) Pty Ltd

المصدر: A Proof-of-concept Study to Assess the Effect of a Range of Doses of Combined Therapy With OZ439 and DSM265 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Participants
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.
McCarthy JS, Ruckle T, Elliott SL, Ballard E, Collins KA, Marquart L, Griffin P, Chalon S, Mohrle JJ. A Single-Dose Combination Study with the Experimental Antimalarials Artefenomel and DSM265 To Determine Safety and Antimalarial Activity against Blood-Stage Plasmodium falciparum in Healthy Volunteers. Antimicrob Agents Chemother. 2019 Dec 20;64(1):e01371-19. doi: 10.1128/AAC.01371-19. Print 2019 Dec 20.

المؤلفون: Queensland Institute of Medical Research

المصدر: An Experimental Study To Characterize the Effectiveness of OZ439 Against Early Plasmodium Falciparum Blood Stage Infection In Healthy Volunteers

المؤلفون: Richmond Pharmacology Limited

المصدر: Open Label Pharmacokinetic Study of OZ439 and Piperaquine Following Administration of OZ439+TPGS Granules for Oral Suspension Alone or With Either Piperaquine Phosphate Tablets or Granules for Oral Solution in the Fasted State in Healthy Volunteers

المؤلفون: Richmond Pharmacology Limited

المصدر: Open Label, Parallel Group Study to Investigate the Pharmacokinetics (PK) Following Oral Co-administration of Piperaquine Phosphate (PQP) Tablets With a Prototype OZ439 + TPGS Formulation in the Fasted State in Healthy Volunteers

المؤلفون: University of Cape Town

المصدر: A Phase I Healthy Volunteer Study Investigating the Safety, Tolerability & Pharmacokinetics of Co-administered Single Doses of OZ439 and Mefloquine

المؤلفون: Quotient Clinical

المصدر: Open Label Study to Investigate the Pharmacokinetics of Prototype Formulations of OZ439 Administered With Piperaquine Phosphate in the Fasted State to Healthy Subjects

المصدر: A Randomised, Placebo-controlled, Dose-escalation Study to Investigate Safety and Toleration of OZ439 OD for 3 Days to Healthy Male and Female Volunteers