Malaria Clinical Trial
Official title:
A Single-Blind, Placebo-Controlled, Randomized First Time in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Dose Escalation of GSK932121 in Healthy Adult Subjects
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.
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 drug resistant malaria which makes it necessary to develop new antimalarial
treatments. In animal studies, GSK932121 is shown to be able to kill the malaria parasite and
is fully active against drug resistant malaria parasites. It is hoped that information
collected on this study will lead to an improved treatment for malaria.
This is a first time in human fusion study which has 3 parts:
Part A - single dose escalation/ food effect: a study where the study drug is given once
only- first at the lowest dose of in a group of participants and the dose increased only if
the previous dose is found to be safe. It also looks at the effect of food on the study drug
in the body Part B - repeat dose escalation: a study where the study drug will be given daily
for up to 7 days - first at a lower dose in a group of participants and the dose increased
for the next group only if the previous dose is found to be safe and Part B - drug-drug
interaction: a study where the study drug will be given daily for up to 7 days at a dose
determined to be safe in previous groups of participants and looking at the effect of the
study drug on other specific approved medications (such as rosiglitazone--a diabetic
medication and rosuvastatin--a cholesterol lowering medication) in the body.
Safety will be assessed by measurement of vital signs, cardiac monitoring, spirometry,
collection of adverse event assessments, renal biomarkers and laboratory safety tests.
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