A First Time in Human Study in Healthy Volunteers to Investigate a New Medicine to Treat Malaria

This is an interventional treatment trial for Malaria focused on measuring Food Effect, Drug-Drug Interaction, Antimalarial, First Time In Human, Single Dose, Repeat Dose Read More

Inclusion Criteria:

• Male or female between 18 and 50 years of age, inclusive
• Females of non-childbearing potential (as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea
• Body weight > 50 kg and BMI within the range 19 - 31 kg/m2 (inclusive)
• QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block

Exclusion Criteria:

• Positive pre-study drug/alcohol screen
• Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
• A positive test for HIV antibody
• History of regular alcohol consumption within 6 months of the study
• Participation in a clinical trial with an investigational product within 30 days or 5 half-lives of the investigational product (whichever is longer) prior to start of the new study
• Exposure to more than four new drugs or within 12 months prior to the first dosing day
• Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication
• History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that would be contraindicated
• Donation of blood or blood products in excess of 500 mL within a 56 day period.
• Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
• Lactating females.
• Unwillingness or inability to follow the procedures outlined in the protocol.
• History of sensitivity to heparin or history of heparin-induced thrombocytopenia if heparin is used to maintain the patency of an intravenous cannula.
• Asthma or a history of asthma
• Smoking or history or regular use of tobacco- or nicotine-containing products within 2 months prior to screening
• Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.