First-in-Human Study of an Oral Plasmodium Falciparum Plasma Membrane Protein Inhibitor
Status:
Completed
Trial end date:
2018-03-09
Target enrollment:
Participant gender:
Summary
Malaria is an infectious disease caused by a parasite that is passed to humans when an
infected mosquito bites a person. About 3.4 billion people live in areas of the world where
malaria is regularly found. In many countries, malaria is one of the leading causes of
illness and death. Despite this, there are a limited number of drugs, called antimalarials,
that can be used to treat malaria and increasing reports of resistance to existing
antimalarials.
The purpose of this research study is to test a new experimental antimalarial drug called
SJ733 to first assess its safety, tolerability and blood levels in healthy adult volunteers.
Single-dose, multi-dose and boosted-dose cohorts (both single and multi-dose) will be
studied. The pharmacoenhancer (booster), cobicistat, will be given in combination with SJ733
in the boosted dose-cohorts.
PRIMARY OBJECTIVES:
- To assess the preliminary safety and tolerability of escalating doses of antimalarial
SJ733 in healthy human volunteers.
- To investigate the pharmacokinetic (PK) profile of escalating doses of antimalarial
SJ733 and its metabolite in healthy human volunteers.
- To identify a dose of SJ733 that can be tested in a separate Phase 1b human malaria
challenge study.
- To assess the preliminary safety and tolerability of SJ733 in healthy adult volunteers
after multiple oral dosing.
- To assess the pharmacokinetics of SJ733 and its metabolite SJ506 after multiple dosing
of SJ733 in healthy adult volunteers.
- To assess the preliminary safety and tolerability of escalating single oral doses of
SJ733 in combination with cobicistat among healthy adult volunteers.
- To assess the pharmacokinetics of SJ733 and its metabolite SJ506 after single oral doses
of SJ733 in combination with cobicistat among healthy adult volunteers.
- To assess the preliminary safety and tolerability of SJ733 in combination with
cobicistat in healthy adult volunteers after multiple oral dosing.
- To assess the pharmacokinetics of SJ733 and its metabolite SJ506 after multiple dosing
of SJ733 in combination with cobicistat among healthy volunteers.
SECONDARY OBJECTIVE:
- To assess the impact of food intake on the pharmacokinetic profile of antimalarial
SJ733.
Phase:
Phase 1
Details
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborators:
Eisai Inc. Global Health Innovative Technology Fund Medicines for Malaria Venture