Food-Effect Bioavailability Study of AQ-13, a Candidate Antimalarial - Full Text View

Food-Effect Bioavailability Study of AQ-13, a Candidate Antimalarial

This study is currently recruiting participants.
Verified by Tulane University Health Sciences Center, April 2007

Sponsors and Collaborators:	Tulane University Health Sciences Center Centers for Disease Control and Prevention
Information provided by:	Tulane University Health Sciences Center
ClinicalTrials.gov Identifier:	NCT00455494

Purpose

The purpose of this study is to test the safety of a 2100 mg dose of AQ-13, a new candidate antimalarial active against drug-resistant P. falciparum infection, and to determine the effect of a standard fatty meal on the absorption of the drug from the gut and its blood levels.

Condition	Intervention	Phase
Malaria	Drug: AQ-13	Phase I

MedlinePlus related topics:

Malaria

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Crossover Assignment, Pharmacokinetics Study

Official Title:	Food-Effect Bioavailability Study of AQ-13, a Candidate Antimalarial

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

Primary Outcome Measures:

Area under the time-concentration curve
Maximal blood concentration
Adverse events

Secondary Outcome Measures:

Effect on heart repolarization (QTc interval change)
Clearance
Terminal elimination half-life

Estimated Enrollment:	14
Study Start Date:	March 2007

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 volunteers 21-45 years of age taking no chronic medications other than birth-control pills

Exclusion Criteria:

Pregnancy,
Breast-feeding,
Chronic disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455494

Contacts


Contact: Fawaz Mzayek, MD, PhD	504-988-1062	fmzayek@tulane.edu

Locations


United States, Louisiana
	Tulane-LSU General Clinical Research Center	Recruiting
	New Orleans, Louisiana, United States, 70112
	Contact: Fawaz Mzayek, MD, PhD 504-988-1062 fmzayek@tulane.edu
	Principal Investigator: Donald J Krogstad, MD

Sponsors and Collaborators

Tulane University Health Sciences Center

Centers for Disease Control and Prevention

Investigators


Principal Investigator:	Donald J Krogstad, MD	Tulane University Health Sciences Center

More Information

Publications:

Mzayek F, Deng H, Mather FJ, Wasilevich EC, Liu H, Hadi CM, Chansolme DH, Murphy HA, Melek BH, Tenaglia AN, Mushatt DM, Dreisbach AW, Lertora JJ, Krogstad DJ. Randomized Dose-Ranging Controlled Trial of AQ-13, a Candidate Antimalarial, and Chloroquine in Healthy Volunteers. PLoS Clin Trials. 2007 Jan 5;2(1):e6 [Epub ahead of print]

Study ID Numbers:	K0154-2, UR3/CCU 418652, U01 CI 000211
First Received:	April 2, 2007
Last Updated:	April 2, 2007
ClinicalTrials.gov Identifier:	NCT00455494
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Tulane University Health Sciences Center:

Drug-resistant malaria

Bioavailability

Food-effect study

Study placed in the following topic categories:

Protozoan Infections

Parasitic Diseases

Malaria

Additional relevant MeSH terms:

Coccidiosis

ClinicalTrials.gov processed this record on October 21, 2008