Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

written informed consent
Male and female (of non-childbearing potential); age 18 to 55 years, in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening
Hematology, clinical chemistry and urinalysis results at screening that are within the local laboratory reference range or, if outside the range, not clinically significant. AST, ALT, lactate dehydrogenase, total bilirubin, haptoglobin and hemoglobin must be within the normal reference ranges
Body weight at least 50kg and body mass index within 18 to 32kg/m2
Good peripheral venous access
Able to communicate well with the investigator, to understand and comply with the requirements of the study
Agree to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and have no current plans to move away from the study area for the duration of the study

Exclusion Criteria:

Any acute illness upon admission to the unit on Day -1 or prior to dosing on Day 1
Use of any other investigational drug within 30 days or five half-lives (whichever is longer) prior to the first dose of MMV390048
history of hypersensitivity to any drugs
history of anaphylaxis or severe allergic reaction
Resting vital signs at either screening or baseline outside the defined ranges
Orthostatic changes in blood pressure and heart rate measurements greater than: 20 mmHg drop in systolic blood pressure; 10 mmHg drop in diastolic blood pressure; 20 beats per minute increase in heart rate
history of clinically significant ECG abnormalities, or any of the defined ECG abnormalities at either screening or baseline
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past five years, regardless of whether there is evidence of local recurrence or metastases
Pregnant or nursing (lactating) women
Women of child-bearing potential
males physiologically capable of conceiving offspring UNLESS the volunteer agrees to use condoms and ensure that his partner(s) is either not of child-bearing potential or uses a highly effective method of contraception for the entire duration of the study and for twelve weeks following the last study drug administration
Smokers (use of tobacco products in the previous three months)
Use of any prescription drugs, herbal supplements, over--the--counter medication or dietary supplements (vitamins included) within four weeks prior to initial dosing
Intake of grapefruit, grapefruit juice or other products containing grapefruit within 28 days of the first drug administration of the study drug
Excessive intake of caffeine drinks or energy drinks within 48 hours before admission defined as more than three 250 ml cups of coffee a day
Donation or loss of 400 ml or more of blood within eight weeks prior to screening or initial dosing
Plasma donation (>100 ml) within 60 days prior to first dosing
Hemoglobin levels below 12.5 g/dl (males) or 11.5 g/dl (females) at screening
Haptoglobin levels outside the reference range
Positive direct anti-globulin test
Liver enzymes other than ALT, AST and lactate dehydrogenase elevated ≥1.5 x ULN within two weeks prior to initial dosing
history of autonomic dysfunction within 3 years and/or recurrent history
History of immunodeficiency diseases, including a confirmed positive HIV test result
Positive Hepatitis B surface antigen or Hepatitis C antibody test result
History of recurrent infection
history of endocrine disease, in particular adrenal disorders such as Cushing's syndrome or Addison's disease, or diabetes mellitus
history of Gilbert's Syndrome
history of photosensitivity
history of any food allergy
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardise the safety of the volunteer or the objectives of the study
History or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or urea values, or abnormal urinary constituents
History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the tests and laboratory assays at screening and/or baseline
Any clinically significant mental disorder that could limit the validity of informed consent or the volunteer's ability to comply with protocol requirements