Status:
TERMINATED
A First Time in Human Study in Healthy Volunteers to Investigate a New Medicine to Treat Malaria
Lead Sponsor:
GlaxoSmithKline
Conditions:
Malaria
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
Malaria is a type of parasitic infection, common in tropical and subtropical regions of the world, including parts of the Americas, Asia, and Africa. In recent years there has been a rapid spread of d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 11 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00811356
Start Date
December 11 2008
End Date
March 30 2009
Last Update
August 3 2017
Active Locations (1)
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1
GSK Investigational Site
Melbourne, Victoria, Australia, 3004