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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014