Studies of AQ-13, a Candidate Aminoquinoline Antimalarial, in Comparison With Chloroquine

• Status: Completed
• Trial end date: 2005-08-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this protocol is to perform Phase 1 (safety/toxicity and pharmacokinetic) Studies of an investigational aminoquinoline antimalarial (AQ-13) in human subjects. The compound to be studied (AQ-13) is being examined because it is active in vitro against Plasmodium falciparum malaria parasites resistant to chloroquine (CQ) and other antimalarials (multi-resistant P. falciparum), and because its safety was similar to that of CQ in preclinical studies performed by SRI International (IND 55,670). AQ-13 was also selected for study because it is active in vivo in two monkey models of human malaria: 1] P. cynomolgi in the rhesus monkey (Macaca mulatta), a model of human infection with P. vivax, and 2] CQ-resistant P. falciparum in the squirrel monkey, a model of human infection with CQ-resistant P. falciparum.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tulane University Health Sciences Center
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); National Institutes of Health (NIH)
• Treatments: Antimalarials; Chloroquine; Chloroquine diphosphate

Criteria

Inclusion Criteria:

• Healthy adult volunteers from 21 to 45 years of age

Exclusion Criteria:

• Chronic medications with the exception of oral contraceptives Pregnancy Breast-feeding