Plasmodium falciparum malaria Infections and Infestations Plasmodium falciparum malaria
Conditions
Interventions
Part 1:
Participants will be randomised to receive a single oral dose of MMV367 or placebo.
Part 2:
Participants will be randomised to receive two single oral doses of MMV367, once in the fasted stat
Sponsors
Medicines for Malaria Venture
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Informed consent and compliance: 1. Must provide written informed consent 2. Must be willing and able to communicate and participate in the whole study Demographics and contraception: 3. Aged 18 to 55 years inclusive at the time of signing the informed consent 4. Must agree to adhere to the contraception requirements Baseline characteristics: 5. Healthy males or non-pregnant, non-lactating healthy females. 6. Body mass index (BMI) of 18.0 to 32.0 kg/m² as measured at screening 7. Weight =50 kg at screening
Exclusion criteria
Exclusion criteria: 1. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients 2. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active 3. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator 4. Blood pressure (supine) at screening or admission outside the range of 90 to 140 mmHg systolic or 50 to 90 mmHg diastolic; and pulse rate outside the range of 45 to 100 bpm, unless deemed not clinically significant by the investigator 5. A decrease of SBP = 20 mmHg after 3 min standing and/or a decrease of DBP =10 mmHg after 3 min standing, at screening 6. History or presence of known structural cardiac abnormalities, family history of long QT syndrome, cardiac syncope or recurrent, idiopathic syncope, exercise-related clinically significant cardiac events. Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG or clinically important abnormalities that may interfere with the interpretation of QT interval changes 7. Presence of sinus node dysfunction, clinically significant PR interval prolongation (>210 msec), intermittent second- or third-degree atrioventricular block, complete bundle branch block, sustained cardiac arrhythmias including (but not limited to) atrial fibrillation or supraventricular tachycardia; any symptomatic arrhythmia with the exception of isolated extra systoles, abnormal T wave morphology which may impact on the QT/QTc assessment, or QTcF >450 msec. Participants with borderline abnormalities may be included if the deviations do not pose a safety risk, and if agreed between the sponsor’s medical monitor and the investigator 8. Participants with a history of cholecystectomy or gall stones 9. Participants with conditions that affect their ability to smell or taste including, but not limited to mouth ulcers, gum disease, nasal surgery and smell and/or taste disorders (e.g. dysosmia, dysgeusia, respiratory and/or sinus infection or cold). Part 1 only. 10. Participants who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening 11. Evidence of current SARS-CoV-2 infection 12. Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis as judged by the investigator Participants with Gilbert’s Syndrome are not allowed. 13. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results 14. Females who are pregnant or lactating (all female participants must have a negative highly sensitive serum pregnancy test at screening and a negative urine pregnancy test at admission) 15. Participants who have received any IMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer 16. Participants who have previously been administered IMP in this study. Participants who have taken part in Part 1 are not permitted to take part in Parts 2 and 3 and participants who have taken part in Part 2 are not permitted to take part in Part 3 17. Donation of blood or plasma within the previous 3 months or loss of greater than 400 ml of blood 18. Participants who are taking, or have taken, any prescribed or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs), physical examinations and change from baseline for vital signs, electrocardiograms (ECGs) and laboratory safety tests, assessed throughout the trial from screening until discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. PK parameters such as AUC, Tmax, Cmax, CL/F, Vz/F, T1/2 and AR, when applicable, measured from Day 1 to Day 7 in Part 1 of the study, Day 1 to Day 14 in Part 2 of the study and Day 1 to Day 9 in Part 3 of the study 2. PK parameters such as AUC, Tmax, Cmax and Frel, as appropriate, under fed and fasted conditions, measured from screening to Day 14 in Part 2 of the study | — |
Countries
England, United Kingdom
Contacts
Public ContactBenoît Bestgen
Outcome results
None listed