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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Tulane University Health Sciences Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Tulane University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT00455494
First received: April 2, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Single Blind
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

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
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: 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
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, U01 CI 000211
Study First Received: April 2, 2007
Last Updated: April 2, 2007
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

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

ClinicalTrials.gov processed this record on August 28, 2014