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NCT02661373 · ClinicalTrials.gov registry record · Phase 1
First-in-Human Study of an Oral Plasmodium Falciparum Plasma Membrane Protein Inhibitor
A Phase 1 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT02661373: Completed Phase 1 study, sponsored by St. Jude Children's Research Hospital.
NCT02661373 is a Phase 1 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02661373, a Phase 1 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study 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 me
Primary Outcome
Number of DLT events will be described at each study dose level. DLT is defined as possibly, probably, or definitely related Grade 4 event, possibly, probably or definitely related Grade 3 event, or possibly, probably, or definitely related Grade 2 methemoglobinemia or anemia (attributed to hemolysis) events.
Interventions
- DRUG Cobicistat
- DRUG SJ733
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2016-03-01 |
| Est. Completion | 2018-03-09 |
| Phase | Phase 1 |
What the finished NCT02661373 record still lists
NCT02661373 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 2 interventions - of which Cobicistat is the first listed.
NCT02661373 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02661373 about?
NCT02661373 is a clinical study titled "First-in-Human Study of an Oral Plasmodium Falciparum Plasma Membrane Protein Inhibitor". 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, t...
What is the current status of trial NCT02661373?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2016-03-01. Estimated completion is 2018-03-09.
What interventions are being tested in trial NCT02661373?
The interventions under investigation include: Cobicistat (DRUG), SJ733 (DRUG).
Who is sponsoring clinical trial NCT02661373?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02661373's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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