BUZZOFF: Antimalarial Drug Effectiveness in Healthy Adults

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

Category:

Infectious Diseases

Diseases Treated:

Malaria

Eligibility Overview:

  • Healthy male or female adults
  • Age 18 to 55 years old
  • Minimum weight of 50 kg with BMI between 18 and 34 kg/m^2
  • Females must be post-menopausal or have documented hysterectomy or bilateral oophorectomy

Description

This study is enrolling participants who are healthy adults that are not taking any medications for a chronic illness. The purpose of this study is to test a new experimental antimalarial drug called SJ733 to see if it is safe for healthy adults to take. Malaria is an infectious disease caused by a parasite that is passed to humans when an infected mosquito bites a person. In many countries, malaria is one of the leading causes of illness and death. There are limited number of drugs (antimalarials) that can be used to treat malaria. Before the research doctors decided to test SJ733 in people, they tested it in animals. The studies in animals showed that SJ733 was able to cause changes in the malaria parasite that made it have difficulty moving and reproducing, and caused it to eventually die. SJ733 is the second antimalarial drug to be tested in people that affects the parasite in this way, but it has the potential to cause fewer side effects based on laboratory tests done on animals.  This research study will test SJ733 given as a single minimum dose and then increasing to a maximum dose. The purpose of testing the different doses of SJ733 is to find the best dose for treating malaria, called the target dose.

Study Goals

  • To see if SJ733 is safe and tolerated in healthy adults.
  • To do pharmacokinetic (PK) testing to find out how SJ733 is used in the body.
  • To find the target dose of SJ733 by giving increasing doses.
  • To find out how food intake effects pharmacokinetic (PK) testing.

Eligibility criteria (among others)

  • Participant is a healthy adult (as certified by comprehensive medical assessment including detailed history and complete physical examination), male or female aged eight-teen (18) to fifty-five (55) years of age (inclusive) at the time of enrollment. Participant, if female, is not of child bearing potential, i.e. permanently sterilized (hysterectomy or bilateral oophorectomy at least six (6) months before screening or is post-menopausal.
  • Participant weighs at least fifty (50) kg and has a body mass index (BMI) between eight-teen and thirty-four kg/m2
  • Participant, if sexually active male, agrees to be abstinent or use condoms for duration of study.
  • Participant does not have significant medical or psychiatric condition that in the opinion of investigator precludes participation in the study. 
  • Participant has no significant illness within two (2) weeks prior to screening visit. Participant can screen after illness resolved for two (2) weeks.
  • Participant has no history of clinical significant electrocardiogram abnormalities.
  • Participant does not have a history of severe drug hypersensitivity including a severe allergic reaction, anaphylaxis or convulsions following any medication, vaccination, or infusion.
  • Participant has not used nicotine containing products within thirty (30) days to screening.
  • Participant agrees not use nonprescription drugs, including vitamins, antacids, and herbal and dietary supplements within seven (7) days prior to taking the single dose of study drug (Day zero [0]) and through Day seven (7). Acetaminophen may be used at doses of less than or equal to 1g/day, and ibuprofen may be used at doses of less than or equal to1.2 g/day.
  • Participant agrees not to consume alcohol for twenty-four (24) hours prior to Day zero (0) and through Day seven (7).

Contact

Aditya Gaur, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.