* CKAF156A2107
Research type
Research Study
Full title
A Phase I, open-label, fixed-sequence, two-period, crossover, drug-drug interaction study to investigate the effect of efavirenz on the pharmacokinetics of ganaplacide and lumefantrine combination in healthy participants
IRAS ID
1005228
Contact name
Deepa Mohanan
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2021-000925-29
Clinicaltrials.gov Identifier
Research summary
Malaria is one of the leading causes of death in the developing world. In 2019 an estimated 229 million cases of Malaria and 409,000 deaths occurred world-wide of which 94% cases occurred in Africa. Standard antimalarial drugs like Chloroquinine and Pyrimethamine have become largely ineffective in malaria endemic regions and therefore there is a strong, unmet medical need for new anti-malaria drugs. Novartis company is developing a new medication called ganaplacide for the treatment of malaria. They are planning to test this drug in combination with Lumefantrine which is an already in-use antimalaria drug for more potent effects.
The primary goal of this study is to examine the effect of efavirenz on how ganaplacide and lumefantrine are absorbed, broken down and eliminated from the body. The rationale behind this is the fact HIV infection is endemic in Africa where Malaria is also endemic. There are high chances of these drugs being used together and it will be useful to know if one is affecting the other's action.
The study involves two treatment periods - one where the drugs ganaplacide and Lumefantrine will be given and the second period where they will be given along with Efavirenz. This will help to understand how administration of Efavirenz is influencing the blood concentrations of Ganaplacide and Lumefantrine which will be measured throughout the study. The cross-over design of the study helps to use the same participants for both treatments which helps avoid the confounding variables if different participants were used for the two treatment periods. In other words, the participants will act as their own control..
20 healthy participants will be studied and healthy volunteers are chosen to minimize the impact of any underlying medical conditions or concomitant medications tat may influence the study outcomes.
The safety of participants will be monitored throughout the study which will last for 55 days from the first baseline visit.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
22/EE/0187
Date of REC Opinion
12 Apr 2022
REC opinion
Further Information Favourable Opinion