Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
A healthy volunteer study to characterise the exposure of the two study medications, following administration of OZ439 + TPGS granules with piperaquine phosphate granules (intended for children) and with piperaquine phosphate tablets (intended for adults). Ideally, to confirm the exposure demonstrated in an earlier bioavailability study.
Full description
A Phase 1 open label parallel group, four arm study conducted in healthy male and female subject aged 18 to 55 years of age. Subjects will receive either treatment A, B, C or D as described below:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
healthy, male or female, any race aged 18-55 years at screening
body mass index of 18-30kg/m2 inclusive; and a total body weight >50kg and up to 100kg at screening
Females must have negative pregnancy test at screening, be non-lactating and of non-childbearing potential confirmed by:
Must agree to use acceptable methods of contraception Males must use acceptable methods of contraception if the male subject's partner could become pregnant from the time of the first administration of treatment or study medication until 3 months following administration of the last dose of study medication
One of the following acceptable methods of contraception must be used:
Condom & occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository)
Surgical sterilisation (vasectomy with documentation of azoospermia) and a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foam/gel/film/cream/suppository)
Female partner uses oral contraceptives (combination oestrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (as above)
Female partner uses medically prescribed topically-applied transdermal contraceptive patch and a barrier method (as above)
Female partner has had documented tubal ligation (sterilization). In addition, a barrier method (as above) must be used
Female partner has had documented placement of an intrauterine device or system and the use of a barrier method (as above)
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 must agree use one of the above-mentioned contraceptive methods, if sexual relationships start during the study or up to 90 days after the last dose of study drug
Exclusion criteria
Male subjects with female partner(s) who is (are) pregnant or lactating from the time of the administration of study medication
Has a clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion
History of allergic reaction to artemisinin-based compounds, 4-aminoquinolines such as piperaquine or any other clinically relevant allergy to drugs or food
Any clinically significant abnormal laboratory, vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at screening or on admission
History or current evidence of any clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal (excluding appendectomy and cholecystectomy), haematological, endocrinological, immunological, metabolic, neurological, oncological, psychiatric, urological or other disease, or current infection
History of post-antibiotic colitis
Electrocardiogram abnormalities in the 12-lead Electrocardiogram (at screening) and/or 24-hour Holter Electrocardiogram (at screening) which in the opinion of the Investigator is clinically relevant or will interfere with the ECG analysis
History of clinically significant Electrocardiogram abnormalities, or any of the following abnormalities at screening or on admission:
Positive results in any of the serology tests for Hepatitis B Surface Antigen, anti Hepatitis core antibody, Hepatitis C antibodies, and HIV 1 and 2 antibodies
Confirmed positive results from urine drug screen (amphetamines, benzodiazepines, cocaine, cannabinoids, opiates, barbiturates, and methadone) or from the alcohol breath test at screening and admission
History or clinical evidence of alcohol abuse, or any recreational drug abuse within the 2 years of screening
Mentally handicapped
Participation in a drug trial within 90 days of drug administration
Use of ANY prescription or over the counter medications, within 3 weeks of study medication administration, or vitamins or herbal supplements within 2 weeks of administration of the study drug, unless prior approval is granted. Intermittent use of paracetamol at doses of up to 2g/day is permitted
Use of moderate/strong inhibitors and/or inducers of CYP450 in 4 weeks of drug administration (or at least 5 half-lives of the compound whichever is the longer)
Veins unsuitable for intravenous puncture or cannulation on either arm (veins difficult to locate, access or puncture, or veins with a tendency to rupture during or after puncture)
Transaminases, bilirubin, serum potassium outside normal range at screening or admission
Haemoglobin < lower limit of normal at screening or admission
Donation of >500mL blood in 90 days prior to drug administration
Must be non-smoker for at least three months before screening. "Tobacco use" includes smoking and the use of snuff and chewing tobacco, and other nicotine containing products. May not use any non-nicotine containing smoking cessation aids, e.g. varenicline, for at least three months before screening
Any consumption of grapefruit, Seville oranges, wild grapes, black mulberries, pomegranates as fruit juice, marmalade or as a raw fruit within 7 days prior to dosing of study drug and throughout the study
Any circumstances or conditions, which may affect full participation in the trial or compliance with the protocol
Legal incapacity or limited legal capacity at screening
Vegetarians, vegans or any dietary restrictions conflicting with the study standardised menus
Primary purpose
Allocation
Interventional model
Masking
55 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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