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

Sponsors and Collaborators:	Tulane University Health Sciences Center National Institutes of Health (NIH)
Information provided by:	Tulane University Health Sciences Center
ClinicalTrials.gov Identifier:	NCT00323375

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 I

MedlinePlus related topics: Malaria

Drug Information available for: Chloroquine diphosphate Chloroquine Chloroquine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study
Official Title:	Randomized Controlled Trial of AQ-13, a Candidate Aminoquinoline Antimalarial, in Comparison With Chloroquine

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

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Donald J. Krogstad, MD

Tulane University Health Sciences Center

More Information

Publications:

Deng H, Liu H, Krogstad FM, Krogstad DJ. Sensitive fluorescence HPLC assay for AQ-13, a candidate aminoquinoline antimalarial, that also detects chloroquine and N-dealkylated metabolites. J Chromatogr B Analyt Technol Biomed Life Sci. 2006 Apr 3;833(2):122-8. Epub 2006 Jan 18.

De D, Krogstad FM, Cogswell FB, Krogstad DJ. Aminoquinolines that circumvent resistance in Plasmodium falciparum in vitro. Am J Trop Med Hyg. 1996 Dec;55(6):579-83.

De D, Krogstad FM, Byers LD, Krogstad DJ. Structure-activity relationships for antiplasmodial activity among 7-substituted 4-aminoquinolines. J Med Chem. 1998 Dec 3;41(25):4918-26.

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
ClinicalTrials.gov Identifier:	NCT00323375 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Tulane University Health Sciences Center:

Malaria
Aminoquinolines
Drug Resistance
Chloroquine Resistance

Study placed in the following topic categories:

Anti-Inflammatory Agents
Protozoan Infections
Chloroquine
Malaria
Anthelmintics
Antimalarials
Analgesics, Non-Narcotic

Chloroquine diphosphate
Parasitic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Antiprotozoal Agents
Physiological Effects of Drugs
Malaria
Antimalarials
Antiparasitic Agents
Sensory System Agents
Therapeutic Uses
Parasitic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Amebicides
Analgesics

Antinematodal Agents
Protozoan Infections
Coccidiosis
Filaricides
Chloroquine
Anthelmintics
Pharmacologic Actions
Analgesics, Non-Narcotic
Chloroquine diphosphate
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009