Intervention: ASPIRIN
Trial phase: Phase 1
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Single dose of 120 mg OZ439 caplet formulation containing nanoparticulate administered orally via the Enterion capsule
Eligibility criteria:
Inclusion Criteria:

Healthy males, or females of non-childbearing potential ie surgically sterilised or post-menopausal
Age 18 to 55 years
Body mass index of 18 to 30 kg/m2 inclusive
Total body weight >50 kg
Healthy as determined by pre-study medical history, physical examination (including body temperature) and 12-lead ECG
Must have haematology, clinical chemistry and urinalysis results at screening that are within the reference range or ncs
Must agree to use an adequate method of contraception
Must demonstrate their ability to swallow an empty size 000 capsule
Must be willing and able to communicate and participate in the whole study
Must provide written informed consent

Exclusion Criteria:

Evidence or history of clinically significant oncological, pulmonary, chronic respiratory, hepatic, cardiovascular, haematological, metabolic, neurological, immunological, nephrological, endocrine or psychiatric disease, or current infection
Clinically relevant abnormalities in the ECG (12 standard leads) and/or QTcF >450 ms (males) or >470 ms (females)
Evidence or history of clinically significant GI disease or surgery (excluding appendectomy or cholecystectomy)
Any condition that could possibly affect drug absorption, eg gastrectomy or diarrhoea
History of post-antibiotic colitis
History of any drug or alcohol abuse in the past 2 years prior to screening
Subjects who have a breath carbon monoxide reading of greater than 10 ppm at screening. Subjects who are tobacco users (including smokers and users of snuff, chewing tobacco and other nicotine or nicotine-containing products) must have stopped use within 90 days before screening
Receipt of an investigational drug or participation in another clinical research study within the previous 3 months
Subjects who are study site employees, or immediate family members of a study site or sponsor employee
Subjects who have previously been enrolled in this study
Use of any prescription or non-prescription medications, vitamins, herbal supplements or dietary supplements within 14 days prior to the first dose
Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab)or human immunodeficiency virus (HIV-1 or HIV-2 antibody) results
Positive urine drug screen result
History of intolerance or hypersensitivity to artemisinins
Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
Presence or history of allergy requiring treatment; hayfever is allowed unless it is active
Donation or loss of >400 mL of blood within the previous 3 months
Haemoglobin result below the lower limit of the reference range
Regular alcohol consumption in males >21 units per week and females >14 units per week
Subjects who do not have suitable veins
Acute diarrhoea or constipation in the 7 days before the predicted first study day.
Presence of non-removable metal objects in the abdomen
Radiation exposure exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years
Failure to satisfy the investigator of fitness to participate for any other reason