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

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ClinicalTrials.gov Identifier: NCT00323375
Recruitment Status : Completed
First Posted : May 9, 2006
Last Update Posted : May 9, 2006
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Malaria Drug: AQ-13 and Chloroquine Phase 1

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of AQ-13, a Candidate Aminoquinoline Antimalarial, in Comparison With Chloroquine
Study Start Date : August 1999
Estimated Study Completion Date : August 2005

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Adverse Events (AEs)
  2. Pharmacokinetic Profile
  3. Effects on the QTc Interval

Secondary Outcome Measures :
  1. Pharmacokinetic Profile of AQ-13 and Chloroquine Metabolites
  2. Pruritus

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00323375

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
National Institutes of Health (NIH)
Principal Investigator: Donald J. Krogstad, MD Tulane University Health Sciences Center
More Information

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)
First Posted: May 9, 2006    Key Record Dates
Last Update Posted: May 9, 2006
Last Verified: August 2005

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

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Chloroquine diphosphate
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antinematodal Agents