A Study to Evaluate the Pharmacokinetics of Oral Formulations of MMV390048 Administered Fasted to Healthy Volunteers

Inclusion Criteria

• healthy male or female (non-childbearing potential) of any race, aged 18 to 55 years
• body weight at least 50kg and a body mass index 18 to 30Kg/m2
• Females must be of non-childbearing potential:
• Natural (spontaneous) post-menopausal defined (amenorrheic for at least 12 months without an alternative medical cause with a screening follicle stimulating hormone level >25IU/L (for post-menopause).
• Premenopausal with irreversible surgical sterilization by hysterectomy
• and/or bilateral oophorectomy or salpingectomy at least 6 months before screening
• Males agree to use acceptable methods of contraception if the male subject's partner could become pregnant from the time of study medication until 120 days after administration of study medication. One of the following acceptable methods of contraception must be used:
• Condom and occlusive cap (diaphragm or cervical/vault cap) with spermicidal foam/gel/film/cream/suppository
• Surgical sterilization (vasectomy with documentation of azoospermia) and an acceptable barrier method (condom or occlusive cap [diaphragm or cervical/vault cap] used with spermicidal foam/gel/film/cream/suppository)
• subject's female partner uses oral contraceptives (combination estrogen / progesterone pills), injectable progesterone or sub-dermal implants and an acceptable barrier method
• subject's female partner uses medically prescribed topically applied transdermal contraceptive patch and an acceptable barrier method
• subject's female partner has undergone documented tubal ligation (female sterilization). In addition, an acceptable barrier method must be used.
• subject's female partner has undergone documented placement of an intrauterine device or intrauterine system. In addition, an acceptable barrier method must be used.
• True abstinence: when in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Abstinent subjects have to agree to use 1 of the above-mentioned contraceptive methods, if they start sexual relationships during the study and for up to 120 days post-study drug
• non-smokers or ex-smokers for more than 90 days prior to screening or smoke no more than 5 cigarettes per day. If users of nicotine products (spray, patch, e-cigarette, etc.) they should use the equivalent of no more than 5 cigarettes /day
• Subjects should not donate egg or sperm from the time of administration of study medication until 120 days post-study drug
• capable of fully understanding and complying with the requirements of the study and must sign the informed consent form prior to undergoing any study-related procedures
• agree to avoid excessive UV radiation exposure (occupational exposure to the sun, sunbathing, tanning salon use, phototherapy, etc.) throughout the study.

Exclusion Criteria

• Male subjects with a female partner(s) who is (are) pregnant or lactating from the time of study medication
• Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means
• Current or recurrent disease (e.g. cardiovascular, neurological, renal, gastrointestinal, oncologic or other conditions) that may affect the action, absorption or disposition of the study medication or could affect clinical assessments or clinical laboratory evaluations
• Current or relevant history of physical or psychiatric illness that may require treatment or make the subject unlikely to fully comply with the requirements or complete the study, or any condition that presents undue risk from the investigational product or study procedures
• Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at ris