NCT00455494

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2007

Completed
Last Updated

December 7, 2020

Status Verified

December 1, 2020

Enrollment Period

1.9 years

First QC Date

April 2, 2007

Last Update Submit

December 4, 2020

Conditions

Malaria

Keywords

Drug-resistant malariaBioavailabilityFood-effect study

Outcome Measures

Primary Outcomes (3)

  • Area under the time-concentration curve

  • Maximal blood concentration

  • Adverse events

Secondary Outcomes (3)

  • Effect on heart repolarization (QTc interval change)

  • Clearance

  • Terminal elimination half-life

Interventions

AQ-13DRUG

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Pregnancy,
  • Breast-feeding,
  • Chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tulane-LSU General Clinical Research Center

New Orleans, Louisiana, 70112, United States

Location

Related Publications (1)

  • 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. doi: 10.1371/journal.pctr.0020006.

    PMID: 17213921BACKGROUND

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Donald J Krogstad, MD

    Tulane University Health Sciences Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 2, 2007

First Posted

April 3, 2007

Study Start

January 1, 2005

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

December 7, 2020

Record last verified: 2020-12

Locations

US(1)