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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by Tulane University Health Sciences Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00455494
First Posted: April 3, 2007
Last Update Posted: April 3, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Centers for Disease Control and Prevention
Information provided by:
Tulane University Health Sciences Center
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Food-Effect Bioavailability Study of AQ-13, a Candidate Antimalarial

Resource links provided by NLM:


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
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): 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:
ClinicalTrials.gov Identifier: NCT00455494     History of Changes
Other Study ID Numbers: K0154-2
UR3/CCU 418652
U01CI000211 ( U.S. NIH Grant/Contract )
First Submitted: April 2, 2007
First Posted: April 3, 2007
Last Update Posted: April 3, 2007
Last Verified: April 2007

Keywords provided by Tulane University Health Sciences Center:
Drug-resistant malaria
Bioavailability
Food-effect study

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents