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

• Status: Terminated
• Trial end date: 2009-03-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if the study drug (antimalarial medication) is safe when given to healthy subjects as a single dose or as repeated doses, to understand the effect of food on single doses of study drug and to determine if the study drug has an effect on other approved medications such as rosiglitazone and rosuvastatin.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Rosiglitazone; Rosuvastatin Calcium

Criteria

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.