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

NCT00323375 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2020-12-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

AQ-13

A treatment dose of AQ-13 (1750 mg base) was administered orally to subjects randomized to AQ-13 over 3 days (as two capsules on days 1 and 2, plus one capsule on day 3).

DRUG

Chloroquine (CQ) Treatment

A treatment dose of CQ (1500 mg CQ base) was administered orally to subjects randomized to CQ over 3 days (as two capsules on days 1 and 2, and one capsule on day 3).

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Tulane University Health Sciences Center

    lead OTHER

Principal Investigators

  • Donald J. Krogstad, MD · Tulane University Health Sciences Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1999-08-01
Primary Completion
2005-06-30
Completion
2005-08-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00323375 on ClinicalTrials.gov