Bioavailability Study of Oral OZ439 Prototype Granule Formulations Administered With Piperaquine Phosphate (PQP) Tablets
Condition: Malaria
MeSH terms: Malaria
Intervention: OZ439 + TPGS; OZ439 Prototype 1; OZ439 Prototype 3; PQP
Intervention MeSH terms: Artefenomel
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Malaria; Bioavailability; Formulation

Summary:

      This is a single-centre, 2-part, randomised, single-dose parallel group study in healthy male
      subjects and female subjects of non-childbearing potential.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males, or healthy females of non-childbearing potential ie surgically
             sterilised or post-menopausal

          -  Body mass index of 18.0 to 30.0 kg/m2 inclusive. Total body weight >50 kg at
             screening.

          -  Must agree to use an adequate method of contraception.

          -  Normal laboratory tests as judged by the Investigator.

          -  Must have QTcF ≤450 ms, QTcB ≤450 ms for male subjects, QTcF ≤470 ms, QTcB ≤470 ms for
             female subjects and PR interval ≤200 ms for screening and pre-dose ECG measurements.

        Exclusion Criteria:

          -  Male subjects who have currently pregnant partners or who have partners planning to be
             pregnant.

          -  Evidence or history of clinically significant disease, or current infection.3.

          -  Clinically relevant abnormalities in the ECG.

          -  Family history of sudden death or of congenital prolongation of the QTc interval or
             known congenital prolongation of the QTc interval or any clinical condition known to
             prolong the QTc interval.

          -  History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia,
             heart rate ≤39 bpm.

          -  Electrolyte disturbances, particularly hypokalaemia, hypocalcaemia or hypomagnesaemia.

          -  History of any drug or alcohol abuse in the past 2 years prior to screening.

          -  Receipt of an investigational drug or participation in another clinical research study
             within 90 days prior to drug administration.

          -  Use of any prescription or non-prescription medications, vitamins, herbal supplements
             or dietary supplements, including protein supplements, within 14 days prior to the
             first dose of study drug.

          -  Positive hepatitis B surface antigen, hepatitis C virus antibody or human
             immunodeficiency virus results.

          -  Clinically significant abnormal biochemistry, haematology or urinalysis.

          -  Positive urine drug screen result.

          -  History of intolerance or hypersensitivity to PQP or any 4-aminoquinoline, or
             ascertained or presumptive hypersensitivity to the active principle and/or formulation
             ingredients; history of anaphylaxis to drugs or allergic reactions in general, that
             the investigator considers may affect the outcome of the study.

          -  Presence or history of allergy requiring treatment; hayfever is allowed unless it is
             active.

          -  Donation or loss of >400 mL of blood within 90 days prior to drug administration.