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

Completed · Phase 1

Conditions studied: Malaria

In brief

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.

Key facts

Study ID

NCT00323375

Run by

Tulane University Health Sciences Center

People needed

122

Starts

1999-08-01

Expected to finish

2005-08-31

Last updated by the study team

2020-12-08

Who can join

Age: 21 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy adult volunteers from 21 to 45 years of age

You may not qualify if…

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

Where it is running

• Tulane-LSU-Charity Hospital General Clinical Research Center — New Orleans, Louisiana, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.