A Phase 1 interventional study of ZY19489 + Ferroquine (FQ) and Placebo in Uncomplicated Malaria, Asymptomatic Condition and Falciparum Malaria, sponsored by Zydus Lifesciences Limited. Recruiting at 1 site in Gabon. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Zydus Lifesciences Limited · Phase 1, Interventional, and Treatment
Malaria is caused by protozoan parasites of the genus Plasmodium and it is the most important parasitic disease in terms of mortality and morbidity. Estimates of 247 million malaria cases and 619.000 deaths worldwide were reported by WHO for the year 2021 (1). Plasmodium falciparum can lead to severe malaria and accounts for 90% of malaria deaths that mainly occur in children below the age of 5 years in Sub-Saharan Africa.
A simplified treatment regimen, ideally a single-day cure (or at most 2-day dosing regimen), of uncomplicated malaria due to P. falciparum would be the magic in the antimalarial armamentarium. Improving treatment adherence is one of the key factors in reducing mortality and morbidity and also the transmission of malaria, and such a regimen would substantially increase adherence. To find a new non-artemisinin combination therapy with a shorter regimen, ideally, a single-dose cure, with low resistance potential would be the aim. The two compounds tested here are ZY19489, a triaminopyrimidine, and ferroquine (FQ), a next-generation 4-aminoquinoline. Both compounds show unique features in terms of long half-life, and activity against current drug-resistant strains.
Therefore, the main goal of this clinical trial is to assess the safety of the ZY19489-FQ combination given as a 1- or 2-day dose regimen.
Total of 36 participants (3 cohorts with up to 12 participants each).The participant will receive the intervention orally once daily for one or two days, following a fasting period of at least 10 hours.Total duration of trial participation for each participant: Approximately 10 weeks (screening visits + 64 days of follow-up).
38 studies on the registry are indexed under Asymptomatic Diseases; 8 are open to participants now.
This study's planned enrollment of 36 is below the median of 50 across 28 interventional studies indexed under Asymptomatic Diseases.
Browse Asymptomatic Diseases studies →Zydus Lifesciences Limited is the lead sponsor of 21 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Signed informed consent obtained prior to participation in the study. In case of participant unable to read and write or otherwise incapable of signing an informed consent, an impartial witnessed consent shall be obtained. Participants who are willing to and are able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria:
Mixed Plasmodium infection as judged by microscopy. 2. Presence of infectious disease or fever (e.g. Body temperature ≥38°C or 100.4°F) within the 14 days prior to enrollment.
Any artemisinin derivative (artesunate, artemether or dihydroartemisinin), quinine, lumefantrine or any other anti-malarial treatment or antibiotic with antimalarial activity (including cotrimoxazole, tetracyclines, quinolones and fluoroquinolones and azithromycin) within 14 days prior to screening.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A single daily dose 600 mg ZY19489 + 600 mg FQ, or 900 mg ZY19489 + 900 mg FQ are selected as the doses to be evaluated in Cohort 1 and 2, respectively. A daily dose of 600 mg ZY19489 + 600 mg FQ will be administered daily for 2 days in Cohort 3. ZY19489-FQ combination or placebo orally after a fasting period of at least 10 h.
Drug: ZY19489 + Ferroquine (FQ)
ZY19489-FQ combination or placebo orally after a fasting period of at least 10 h.
Drug: Placebo
Drug page: Ferroquine
ZY19489-FQ combination or placebo orally after a fasting period of at least 10 h.
ZY19489-FQ combination or placebo orally after a fasting period of at least 10 h.
incidence, severity and relationship to ZY19489-FQ of treatment emergent adverse events
To evaluate the safety and tolerability of ZY19489-FQ combination in African adult asymptomatic carriers of Plasmodium falciparum mono-infections.
Time frame: Day 0 to Day 64
Area under the curve from the time of dosing to the last measurable concentration (AUC0-t).
Estimation of PK parameters of ZY19489, its major metabolite and FQ and its major metabolite using noncompartmental method.To characterize the PK of ZY19489-FQ combination in African asymptomatic adult carriers of Plasmodium falciparum mono-infections
Time frame: Day 0 to Day 64
Area under the curve from the time of dosing to the infinity (AUC0-∞)
Estimation of PK parameters of ZY19489, its major metabolite and FQ and its major metabolite using noncompartmental method.To characterize the PK of ZY19489-FQ combination in African asymptomatic adult carriers of Plasmodium falciparum mono-infections
Time frame: Day 0 to Day 64
Maximum plasma concentration (Cmax)
Estimation of PK parameters of ZY19489, its major metabolite and FQ and its major metabolite using noncompartmental method.To characterize the PK of ZY19489-FQ combination in African asymptomatic adult carriers of Plasmodium falciparum mono-infections
Time frame: Day 0 to Day 64
Time to reach maximum plasma concentration (Tmax)
Estimation of PK parameters of ZY19489, its major metabolite and FQ and its major metabolite using noncompartmental method.To characterize the PK of ZY19489-FQ combination in African asymptomatic adult carriers of Plasmodium falciparum mono-infections
Time frame: Day 0 to Day 64
Terminal half life (t1/2)
Estimation of PK parameters of ZY19489, its major metabolite and FQ and its major metabolite using noncompartmental method.To characterize the PK of ZY19489-FQ combination in African asymptomatic adult carriers of Plasmodium falciparum mono-infections
Time frame: Day 0 to Day 64
Clearance (CL/F)
Estimation of PK parameters of ZY19489, its major metabolite and FQ and its major metabolite using noncompartmental method.To characterize the PK of ZY19489-FQ combination in African asymptomatic adult carriers of Plasmodium falciparum mono-infections
Time frame: Day 0 to Day 64
Volume of distribution (Vd/F)
Estimation of PK parameters of ZY19489, its major metabolite and FQ and its major metabolite using noncompartmental method.To characterize the PK of ZY19489-FQ combination in African asymptomatic adult carriers of Plasmodium falciparum mono-infections
Time frame: Day 0 to Day 64
Elimination rate constant (λ)
Estimation of PK parameters of ZY19489, its major metabolite and FQ and its major metabolite using noncompartmental method.To characterize the PK of ZY19489-FQ combination in African asymptomatic adult carriers of Plasmodium falciparum mono-infections
Time frame: Day 0 to Day 64
Parasite reduction ratio between baseline and 48h post-treatment (PRR48) and corresponding parasite clearance half-life (PCT½).
To describe the parasite clearance capacity of ZY19489-FQ combination in African asymptomatic adult carriers of Plasmodium falciparum mono-infections
Time frame: Day 0 to Day 64
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2024 (actual). Primary completion is estimated for Feb 2025, 5 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Ferroquine