Randomized dose-ranging controlled trial of AQ-13, a candidate antimalarial, and chloroquine in healthy volunteers.

ABSTRACT:

Objectives

To determine: (1) the pharmacokinetics and safety of an investigational aminoquinoline active against multidrug-resistant malaria parasites (AQ-13), including its effects on the QT interval, and (2) whether it has pharmacokinetic and safety profiles similar to chloroquine (CQ) in humans.

Design

Phase I double-blind, randomized controlled trials to compare AQ-13 and CQ in healthy volunteers. Randomizations were performed at each step after completion of the previous dose.

Setting

Tulane-Louisiana State University-Charity Hospital General Clinical Research Center in New Orleans.

Participants

126 healthy adults 21-45 years of age.

Interventions

10, 100, 300, 600, and 1,500 mg oral doses of CQ base in comparison with equivalent doses of AQ-13.

SUBMITTER: Mzayek F 

PROVIDER: S-EPMC1764434 | biostudies-literature | 2007 Jan

REPOSITORIES: biostudies-literature