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NCT00323375 · ClinicalTrials.gov registry record · Phase 1
Studies of AQ-13, a Candidate Aminoquinoline Antimalarial, in Comparison With Chloroquine
A Phase 1 study, sponsored by Tulane University Health Sciences Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 122
- Enrollment target
NCT00323375 is a Phase 1 study that has completed, run by Tulane University Health Sciences Center. The registered enrollment target is 122 participants.
The verdict
NCT00323375, a Phase 1 study, has completed, sponsored by Tulane University Health Sciences Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 122 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG AQ-13
- DRUG Chloroquine (CQ) Treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 1999-08-01 |
| Est. Completion | 2005-08-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00323375
The ClinicalTrials.gov registry entry for NCT00323375 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tulane University Health Sciences Center, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which AQ-13 is the first listed.
NCT00323375 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00323375 about?
NCT00323375 is a clinical study titled "Studies of AQ-13, a Candidate Aminoquinoline Antimalarial, in Comparison With Chloroquine". 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 paras...
What is the current status of trial NCT00323375?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 122 participants. The study started on 1999-08-01. Estimated completion is 2005-08-31.
What interventions are being tested in trial NCT00323375?
The interventions under investigation include: AQ-13 (DRUG), Chloroquine (CQ) Treatment (DRUG).
Who is sponsoring clinical trial NCT00323375?
This trial is sponsored by Tulane University Health Sciences Center, which has 10 total clinical trials registered on ClinicalTrials.gov.
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