First-in-Human Study of an Oral Plasmodium Falciparum Plasma Membrane Protein Inhibitor

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.

Conditions

• Malaria

Interventions

DRUG

SJ733

SJ733 is an oral, novel inhibitor of Plasmodium Falciparum plasma membrane protein PFATP4. It will be administered as a single, multi, or boosted oral dose.

DRUG

Cobicistat

Commercially available cobicistat 150 mg tablets will be used. It will be administered as a single oral dose together with SJ733.

Sponsors & Collaborators

• Medicines for Malaria Venture

  collaborator OTHER

• Eisai Inc.

  collaborator INDUSTRY

• Global Health Innovative Technology Fund

  collaborator OTHER

• St. Jude Children's Research Hospital

  lead OTHER

Principal Investigators

• Aditya H. Gaur, MD · St. Jude Children's Research Hospital

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-03-01

Primary Completion

2018-03-09

Completion

2018-03-09

FDA Drug

Yes

Countries

• United States

Study Locations