Phase 1 Studies of AQ-13, a Candidate Aminoquinoline Antimalarial, in Comparison With Chloroquine

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Tulane University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT00323375
First received: May 5, 2006
Last updated: NA
Last verified: August 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Malaria
Drug: AQ-13 and Chloroquine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of AQ-13, a Candidate Aminoquinoline Antimalarial, in Comparison With Chloroquine

Resource links provided by NLM:


Further study details as provided by Tulane University Health Sciences Center:

Primary Outcome Measures:
  • Adverse Events (AEs)
  • Pharmacokinetic Profile
  • Effects on the QTc Interval

Secondary Outcome Measures:
  • Pharmacokinetic Profile of AQ-13 and Chloroquine Metabolites
  • Pruritus

Estimated Enrollment: 122
Study Start Date: August 1999
Estimated Study Completion Date: August 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323375

Locations
United States, Louisiana
Tulane-LSU-Charity Hospital General Clinical Research Center
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
Tulane University Health Sciences Center
Investigators
Principal Investigator: Donald J. Krogstad, MD Tulane University Health Sciences Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00323375     History of Changes
Other Study ID Numbers: Don Krogstad, K 0154 (Phase 1), FDA Phase 1 (FD R 01692), CDC (UR3/CCU 418652)
Study First Received: May 5, 2006
Last Updated: May 5, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Tulane University Health Sciences Center:
Malaria
Aminoquinolines
Drug Resistance
Chloroquine Resistance

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Antimalarials
Chloroquine
Chloroquine diphosphate
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Amebicides
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014