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Article ; Online: Concentration-QT modelling of the novel DHFR inhibitor P218 in healthy male volunteers.

Täubel, Jӧrg / Lorch, Ulrike / Ferber, Georg / Spencer, Christopher S / Freier, Anne / Coates, Simon / El Gaaloul, Myriam / Donini, Cristina / Chughlay, Mohamed Farouk / Chalon, Stephan

British journal of clinical pharmacology

2021 Volume 88, Issue 1, Page(s) 128–137

Abstract: Aims: Given the increasing emergence of drug resistance in Plasmodium, new antimalarials are urgently required. P218 is an aminopyridine that inhibits dihydrofolate reductase being developed as a malaria chemoprotective drug. Assessing the effect of new ...

Abstract	Aims: Given the increasing emergence of drug resistance in Plasmodium, new antimalarials are urgently required. P218 is an aminopyridine that inhibits dihydrofolate reductase being developed as a malaria chemoprotective drug. Assessing the effect of new compounds on cardiac intervals is key during early drug development to determine their cardiac safety. Methods: This double-blind, randomized, placebo-controlled, parallel group study evaluated the effect of P218 on electrocardiographic parameters following oral administration of seven single-ascending doses up to 1000 mg in 56 healthy volunteers. Participants were randomized to treatment or placebo at a 3:1 ratio. P218 was administered in the fasted state with standardized lunch served 4 hours after dosing. 12-lead ECGs were recorded in triplicate at regular intervals on the test day, and at 48, 72, 120, 168, 192 and 240 hours thereafter. Blood samples for pharmacokinetic evaluations were collected at similar time points. Concentration-effect modelling was used to assess the effect of P218 and its metabolites on cardiac intervals. Results: Concentration-effect analysis showed that P218 does not prolong the QTcF, J-Tpeak or TpTe interval at all doses tested. No significant changes in QRS or PR intervals were observed. Two-sided 90% confidence intervals of subinterval effects of P218 and its metabolites were consistently below the regulatory concern threshold for all doses. Study sensitivity was confirmed by significant shortening of QTcF after a meal. Conclusion: Oral administration of P218 up to 1000 mg does not prolong QTcF and does not significantly change QRS or PR intervals, suggesting low risk for drug-induced proarrhythmia.
MeSH term(s)	Antimalarials/adverse effects ; Cross-Over Studies ; Dose-Response Relationship, Drug ; Double-Blind Method ; Electrocardiography ; Healthy Volunteers ; Heart Rate ; Humans ; Malaria/drug therapy ; Male
Chemical Substances	Antimalarials
Language	English
Publishing date	2021-07-09
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.14933
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Article ; Online: Safety and efficacy of four drug regimens versus standard-of-care for the treatment of symptomatic outpatients with COVID-19: A randomised, open-label, multi-arm, phase 2 clinical trial.

Chandiwana, Nomathemba / Kruger, Chelsea / Johnstone, Hilary / Chughlay, Mohamed Farouk / Ju, Chung / Kim, Byungsu / Dineka, Yengiwe / Arbe-Barnes, Sarah / Miller, Robert / Owen, Andrew / Hill, Andrew / Windgassen, Daniel / Abla, Nada / Marrast, Anne Claire / Duparc, Stephan / Francois Venter, Willem Daniel

EBioMedicine

2022 Volume 86, Page(s) 104322

Abstract: Background: This exploratory study investigated four repurposed anti-infective drug regimens in outpatients with COVID-19.: Methods: This phase 2, single centre, randomised, open-label, clinical trial was conducted in South Africa between 3rd ... ...

Abstract	Background: This exploratory study investigated four repurposed anti-infective drug regimens in outpatients with COVID-19. Methods: This phase 2, single centre, randomised, open-label, clinical trial was conducted in South Africa between 3rd September 2020 and 23rd August 2021. Symptomatic outpatients aged 18-65 years, with RT-PCR confirmed SARS-CoV-2 infection were computer randomised (1:1:1:1:1) to standard-of-care (SOC) with paracetamol, or SOC plus artesunate-amodiaquine (ASAQ), pyronaridine-artesunate (PA), favipiravir plus nitazoxanide (FPV + NTZ), or sofosbuvir-daclatasvir (SOF-DCV). The primary endpoint was the incidence of viral clearance, i.e., the proportion of patients with a negative SARS-CoV-2 RT-PCR on day 7, compared to SOC using a log-binomial model in the modified intention-to-treat (mITT) population. Findings: The mITT population included 186 patients: mean age (SD) 34.9 (10.3) years, body weight 78.2 (17.1) kg. Day 7 SARS-CoV-2 clearance rates (n/N; risk ratio [95% CI]) were: SOC 34.2% (13/38), ASAQ 38.5% (15/39; 0.80 [0.44, 1.47]), PA 30.3% (10/33; 0.69 [0.37, 1.29]), FPV + NTZ 27.0% (10/37; 0.60 [0.31, 1.18]) and SOF-DCV 23.5% (8/34; 0.47 [0.22, 1.00]). Three lower respiratory tract infections occurred (PA 6.1% [2/33]; SOF-DCV 2.9% [1/34]); two required hospitalisation (PA, SOF-DCV). There were no deaths. Adverse events occurred in 55.3% (105/190) of patients, including one serious adverse event (pancytopenia; FPV + NTZ). Interpretation: There was no statistical difference in viral clearance for any regimen compared to SOC. All treatments were well tolerated. Funding: Medicines for Malaria Venture, with funding from the UK Foreign, Commonwealth and Development Office, within the Covid-19 Therapeutics Accelerator in partnership with Wellcome, the Bill and Melinda Gates Foundation, and Mastercard.
Language	English
Publishing date	2022-11-01
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	2851331-9
ISSN	2352-3964
ISSN (online)	2352-3964
DOI	10.1016/j.ebiom.2022.104322
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Article ; Online: Safety and efficacy of four drug regimens versus standard-of-care for the treatment of symptomatic outpatients with COVID-19

Nomathemba Chandiwana / Chelsea Kruger / Hilary Johnstone / Mohamed Farouk Chughlay / Chung Ju / Byungsu Kim / Yengiwe Dineka / Sarah Arbe-Barnes / Robert Miller / Andrew Owen / Andrew Hill / Daniel Windgassen / Nada Abla / Anne Claire Marrast / Stephan Duparc / Willem Daniel Francois Venter

EBioMedicine, Vol 86, Iss , Pp 104322- (2022)

A randomised, open-label, multi-arm, phase 2 clinical trialResearch in context

2022

Abstract: Summary: Background: This exploratory study investigated four repurposed anti-infective drug regimens in outpatients with COVID-19. Methods: This phase 2, single centre, randomised, open-label, clinical trial was conducted in South Africa between 3rd ... ...

Abstract	Summary: Background: This exploratory study investigated four repurposed anti-infective drug regimens in outpatients with COVID-19. Methods: This phase 2, single centre, randomised, open-label, clinical trial was conducted in South Africa between 3rd September 2020 and 23rd August 2021. Symptomatic outpatients aged 18–65 years, with RT-PCR confirmed SARS-CoV-2 infection were computer randomised (1:1:1:1:1) to standard-of-care (SOC) with paracetamol, or SOC plus artesunate-amodiaquine (ASAQ), pyronaridine-artesunate (PA), favipiravir plus nitazoxanide (FPV + NTZ), or sofosbuvir-daclatasvir (SOF-DCV). The primary endpoint was the incidence of viral clearance, i.e., the proportion of patients with a negative SARS-CoV-2 RT-PCR on day 7, compared to SOC using a log-binomial model in the modified intention-to-treat (mITT) population. Findings: The mITT population included 186 patients: mean age (SD) 34.9 (10.3) years, body weight 78.2 (17.1) kg. Day 7 SARS-CoV-2 clearance rates (n/N; risk ratio [95% CI]) were: SOC 34.2% (13/38), ASAQ 38.5% (15/39; 0.80 [0.44, 1.47]), PA 30.3% (10/33; 0.69 [0.37, 1.29]), FPV + NTZ 27.0% (10/37; 0.60 [0.31, 1.18]) and SOF-DCV 23.5% (8/34; 0.47 [0.22, 1.00]). Three lower respiratory tract infections occurred (PA 6.1% [2/33]; SOF-DCV 2.9% [1/34]); two required hospitalisation (PA, SOF-DCV). There were no deaths. Adverse events occurred in 55.3% (105/190) of patients, including one serious adverse event (pancytopenia; FPV + NTZ). Interpretation: There was no statistical difference in viral clearance for any regimen compared to SOC. All treatments were well tolerated. Funding: Medicines for Malaria Venture, with funding from the UK Foreign, Commonwealth and Development Office, within the Covid-19 Therapeutics Accelerator in partnership with Wellcome, the Bill and Melinda Gates Foundation, and Mastercard.
Keywords	SARS-CoV-2 ; Pyronaridine-artesunate ; Artesunate-amodiaquine ; Favipiravir + nitazoxanide ; Sofosbuvir-daclatasvir ; Outpatient ; Medicine ; R ; Medicine (General) ; R5-920
Subject code	610
Language	English
Publishing date	2022-12-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Liver Enzyme Elevations in

Chughlay, Mohamed Farouk / Akakpo, Samantha / Odedra, Anand / Csermak-Renner, Katalin / Djeriou, Elhadj / Winnips, Cornelis / Leboulleux, Didier / Gaur, Aditya H / Shanks, G Dennis / McCarthy, James / Chalon, Stephan

The American journal of tropical medicine and hygiene

2020 Volume 103, Issue 1, Page(s) 378–393

Abstract: Malaria volunteer infection studies (VISs) accelerate new drug and vaccine development. In the induced blood-stage malaria (IBSM) model, volunteers are inoculated with erythrocytes infected ... ...

Abstract	Malaria volunteer infection studies (VISs) accelerate new drug and vaccine development. In the induced blood-stage malaria (IBSM) model, volunteers are inoculated with erythrocytes infected with
MeSH term(s)	Acrylamides/adverse effects ; Adamantane/adverse effects ; Adamantane/analogs & derivatives ; Adult ; Alanine Transaminase/metabolism ; Aminopyridines/adverse effects ; Aminoquinolines/adverse effects ; Antimalarials/adverse effects ; Aspartate Aminotransferases/metabolism ; Chemical and Drug Induced Liver Injury/epidemiology ; Chemical and Drug Induced Liver Injury/etiology ; Chemical and Drug Induced Liver Injury/metabolism ; Erythrocyte Transfusion ; Erythrocytes/parasitology ; Female ; Ferrous Compounds/adverse effects ; Healthy Volunteers ; Heterocyclic Compounds, 4 or More Rings/adverse effects ; Humans ; Indoles/adverse effects ; Isoquinolines/adverse effects ; Malaria, Falciparum/drug therapy ; Male ; Metallocenes/adverse effects ; Parasitemia/drug therapy ; Peroxides/adverse effects ; Piperazines/adverse effects ; Plasmodium falciparum ; Primaquine/adverse effects ; Pyrimidines/adverse effects ; Quinolines/adverse effects ; Spiro Compounds/adverse effects ; Sulfones/adverse effects ; Triazoles/adverse effects ; Young Adult
Chemical Substances	ACT-451840 ; Acrylamides ; Aminopyridines ; Aminoquinolines ; Antimalarials ; Ferrous Compounds ; Heterocyclic Compounds, 4 or More Rings ; Indoles ; Isoquinolines ; MMV390048 ; Metallocenes ; NITD 609 ; Peroxides ; Piperazines ; Pyrimidines ; Quinolines ; SJ733 ; Spiro Compounds ; Sulfones ; Triazoles ; DSM265 (0Q42P4YI6B) ; ferroquine (8D81JS19ET) ; piperaquine (A0HV2Q956Y) ; Aspartate Aminotransferases (EC 2.6.1.1) ; Alanine Transaminase (EC 2.6.1.2) ; Primaquine (MVR3634GX1) ; Adamantane (PJY633525U) ; artefenomel (RIK029813G)
Language	English
Publishing date	2020-04-16
Publishing country	United States
Document type	Journal Article
ZDB-ID	2942-7
ISSN	1476-1645 ; 0002-9637
ISSN (online)	1476-1645
ISSN	0002-9637
DOI	10.4269/ajtmh.19-0846
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Article ; Online: Chemoprotective Antimalarial Activity of P218 against Plasmodium falciparum: A Randomized, Placebo-Controlled Volunteer Infection Study.

Chughlay, Mohamed Farouk / El Gaaloul, Myriam / Donini, Cristina / Campo, Brice / Berghmans, Pieter-Jan / Lucardie, Alexander / Marx, Michael W / Cherkaoui-Rbati, Mohammed H / Langdon, Grant / Angulo-Barturen, Iñigo / Viera, Sara / Rosanas-Urgell, Anna / Van Geertruyden, Jean-Pierre / Chalon, Stephan

The American journal of tropical medicine and hygiene

2021 Volume 104, Issue 4, Page(s) 1348–1358

Abstract: P218 is a highly selective dihydrofolate reductase inhibitor with potent in vitro activity against pyrimethamine-resistant Plasmodium falciparum. This single-center, randomized, double-blind, placebo-controlled phase Ib study evaluated P218 safety, ... ...

Abstract	P218 is a highly selective dihydrofolate reductase inhibitor with potent in vitro activity against pyrimethamine-resistant Plasmodium falciparum. This single-center, randomized, double-blind, placebo-controlled phase Ib study evaluated P218 safety, pharmacokinetics, and chemoprotective efficacy in a P. falciparum sporozoite (PfSPZ) volunteer infection study (VIS). Consecutive dose safety and tolerability were evaluated (cohort 1), with participants receiving two oral doses of P218 1,000 mg 48 hours apart (n = 6), or placebo (n = 2). P218 chemoprotective efficacy was assessed (cohorts 2 and 3) with direct venous inoculation of 3,200 aseptic, cryopreserved PfSPZ (NF54 strain) followed 2 hours later with two P218 doses of 1,000 mg (cohort 2, n = 9) or 100 mg (cohort 3, n = 9) administered 48 hours apart, or placebo (n = 6). Parasitemia was assessed from day 7 using quantitative PCR targeting the var gene acidic terminal sequence (varATS qPCR). By day 28, all participants in cohort 2 (P218 1,000 mg) and 8/9 in cohort 3 (P218 100 mg) were sterilely protected post-PfSPZ VIS, confirming P218 P. falciparum chemoprotective activity. With placebo, all six participants became parasitemic (geometric mean time to positive parasitemia 10.6 days [90% CI: 9.9-11.4]). P218 pharmacokinetics were similar in participants with or without induced infection. Adverse events of any cause occurred in 45.8% (11/24) of participants who received P218 and 50.0% (4/8) following placebo; all were mild/moderate in severity, transient, and self-limiting. There were no clinically relevant changes in laboratory parameters, vital signs, or electrocardiograms. P218 displayed excellent chemoprotective efficacy against P. falciparum with favorable safety and tolerability.
Language	English
Publishing date	2021-02-08
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2942-7
ISSN	1476-1645 ; 0002-9637
ISSN (online)	1476-1645
ISSN	0002-9637
DOI	10.4269/ajtmh.20-1165
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Article ; Online: N-acetylcysteine for non-paracetamol drug-induced liver injury: a systematic review.

Chughlay, Mohamed Farouk / Kramer, Nicole / Spearman, C Wendy / Werfalli, Mahmoud / Cohen, Karen

British journal of clinical pharmacology

2016 Volume 81, Issue 6, Page(s) 1021–1029

Abstract: Aims: N-acetylcysteine (NAC) may be useful in the management of non-paracetamol drug-induced liver injury (DILI). Our objective was to review systematically evidence for the use of NAC as a therapeutic option for non-paracetamol DILI.: Methods: We ... ...

Abstract	Aims: N-acetylcysteine (NAC) may be useful in the management of non-paracetamol drug-induced liver injury (DILI). Our objective was to review systematically evidence for the use of NAC as a therapeutic option for non-paracetamol DILI. Methods: We searched for randomized controlled trials (RCTs) and prospective cohort studies. We searched several bibliographic databases, grey literature sources, conference proceedings and ongoing trials. Our pre-specified primary outcomes were all cause and DILI related mortality, time to normalization of liver biochemistry and adverse events. Secondary outcomes were proportion receiving liver transplant, time to transplantation, transplant-free survival and hospitalization duration. Results: We identified one RCT of NAC vs. placebo in patients with non-paracetamol acute liver failure. There was no difference in the primary outcomes of overall survival at 3 weeks between NAC [70%, 95% confidence interval (CI) = 60%, 81%, n = 81] and placebo (66%, 95% CI = 56%, 77%, n = 92). NAC significantly improved the secondary outcomes of transplant-free survival compared with placebo: 40% NAC (95% CI = 28%, 51%) vs. 27% placebo (95% CI = 18%, 37%). A subgroup analysis according to aetiology found improved transplant-free survival in patients with non-paracetamol DILI, NAC (58%, n = 19) vs. placebo (27%, n = 26), odds ratio (OR) 0.27 (95% CI = 0.076, 0.942). Overall survival was similar, NAC (79%) vs. placebo (65%);, OR 0.50 (95% CI = 0.13, 1.98). Conclusion: Current available evidence is limited and does not allow for any firm conclusions to be made regarding the role of NAC in non-paracetamol DILI. We therefore highlight the need for further research in this area.
MeSH term(s)	Acetylcysteine/therapeutic use ; Chemical and Drug Induced Liver Injury/drug therapy ; Free Radical Scavengers/therapeutic use ; Humans
Chemical Substances	Free Radical Scavengers ; Acetylcysteine (WYQ7N0BPYC)
Language	English
Publishing date	2016-03-02
Publishing country	England
Document type	Journal Article ; Review ; Systematic Review
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.12880
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Article ; Online: N-acetylcysteine for non-paracetamol drug-induced liver injury: a systematic review protocol.

Chughlay, Mohamed Farouk / Kramer, Nicole / Werfalli, Mahmoud / Spearman, Wendy / Engel, Mark Emmanuel / Cohen, Karen

Systematic reviews

2015 Volume 4, Page(s) 84

Abstract: Background: Drug-induced liver injury (DILI) refers to acute or chronic liver injury that may occur as a consequence of using drugs and herbal or dietary supplements. Specific therapies for DILI are limited. There is considerable evidence for efficacy ... ...

Abstract	Background: Drug-induced liver injury (DILI) refers to acute or chronic liver injury that may occur as a consequence of using drugs and herbal or dietary supplements. Specific therapies for DILI are limited. There is considerable evidence for efficacy and safety of N-acetylcysteine (NAC) in management of paracetamol-induced liver injury. More recently, research has explored the use of NAC in non-paracetamol drug-induced liver injury. It is important to summarise the evidence of NAC for non-paracetamol DILI to determine if NAC may be considered a therapeutic option in this condition. Methods/design: We will conduct a systematic review of the benefit and harm of NAC in non-paracetamol drug-induced liver injury. Primary and secondary outcomes of interest are pre-specified. Primary outcomes include all-cause mortality, mortality due to DILI, time to normalisation of liver biochemistry (e.g. return of alanine transaminase to <100 U/l and/or international normalized ratio (INR) <1.5) and adverse events. Secondary outcomes include transplantation rate, time to transplantation, transplant-free survival and duration of hospitalisation. We will include randomized controlled trials (RCTs) and prospective cohort studies. RCTs will contribute to the evaluation of safety and efficacy of NAC, whereas, the cohort studies will contribute exclusively to the evaluation of safety. We will search several bibliographic databases (including PubMed, Scopus, CINAHL, CENTRAL), grey literature sources, conference proceedings and ongoing trials. Following data extraction and assessment of the risk of bias, we will conduct a meta-analysis if feasible, as well as subgroup analyses. We will assess and explore clinical and statistical heterogeneity. Discussion: The aim of this review is to provide evidence on the effectiveness and safety of NAC in non-paracetamol DILI. We anticipate that the results could aid health care practitioners, researchers and policymakers in the decision-making regarding the use of NAC in patients with non-paracetamol DILI. Systematic review registration: PROSPERO CRD42014008771.
MeSH term(s)	Acetylcysteine/therapeutic use ; Chemical and Drug Induced Liver Injury/drug therapy ; Clinical Protocols ; Free Radical Scavengers/therapeutic use ; Humans ; Research Design
Chemical Substances	Free Radical Scavengers ; Acetylcysteine (WYQ7N0BPYC)
Language	English
Publishing date	2015-06-12
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2662257-9
ISSN	2046-4053 ; 2046-4053
ISSN (online)	2046-4053
ISSN	2046-4053
DOI	10.1186/s13643-015-0075-6
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Article ; Online: Concentration-QT modelling of the novel DHFR inhibitor P218 in healthy male volunteers.

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Article ; Online: Safety and efficacy of four drug regimens versus standard-of-care for the treatment of symptomatic outpatients with COVID-19: A randomised, open-label, multi-arm, phase 2 clinical trial.

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Article ; Online: Safety and efficacy of four drug regimens versus standard-of-care for the treatment of symptomatic outpatients with COVID-19

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Article ; Online: Chemoprotective Antimalarial Activity of P218 against Plasmodium falciparum: A Randomized, Placebo-Controlled Volunteer Infection Study.

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Article ; Online: N-acetylcysteine for non-paracetamol drug-induced liver injury: a systematic review.

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Article ; Online: N-acetylcysteine for non-paracetamol drug-induced liver injury: a systematic review protocol.

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