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NCT01871142 · ClinicalTrials.gov registry record · Phase 1
Evaluation of the Attenuation by Aes-103 of Hypoxia Mediated Decrements in Endurance Exercise Performance
A Phase 1 study, sponsored by Colorado State University.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01871142 is a Phase 1 study that has completed, run by Colorado State University. The registered enrollment target is 12 participants.
The verdict
NCT01871142, a Phase 1 study, has completed, sponsored by Colorado State University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
In low oxygen environments, such as high-altitude, some adults may become ill and suffer from acute mountain sickness. Further, all adults will find that exercising becomes much more difficult when compared with exercise at lower altitudes (e.g. sea-level). The purpose of this investigation is to study the effects of a new medicine called Aes-103. A company called AesRx, LLC makes this medicine. The active ingredient in the medicine is 5-Hydroxymethyl-2-Furfural (5HMF), a naturally occurring substance that can be found in coffee, honey, dried fruits, fruit juices, malt, barley, Balsamic vinegar and caramel.The investigators believe that Aes-103 may help people adjust to high-altitude quickly and prevent them from becoming ill. The purpose of the study is to determine if Aes-103 will promote endurance performance in low oxygen environments in healthy adult humans. Aes-103 is currently being investigated by AesRx, LLC (Newton, MA) in collaboration with the National Heart, Lung and Blood Institute of the NIH (Bethesda, MD) as a potential anti-sickling agent in sickle cell disease. Sickle-cell disease is characterized by problems in blood that prevent blood cells from carrying oxygen. Aes-103 might be able to help blood cells carry more oxygen. It is for this reason that the investigators in this study believe Aes-103 might help people adjust to high-altitude quickly. There are no known special safety considerations with the active ingredient in Aes-103 (5-HMF). In recent, placebo controlled, clinical safety tests, Aes-103 was given in single doses of 300 mg, 1000 mg,2000 mg and 4000 mg to healthy normal volunteers. Additionally, the toxicological effects of Aes-103 have been studied when given acutely, sub-acutely, and chronically in rodents, and for up to 28 days in dogs. Based on these safety studies, single doses of Aes-103 are expected to have no significant negative/toxicological effect at the doses being evaluated in this study.
Interventions
- DRUG Placebo
- DRUG Aes-103
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2013-03 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01871142
The ClinicalTrials.gov registry entry for NCT01871142 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Colorado State University, which has 94 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01871142 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01871142 about?
NCT01871142 is a clinical study titled "Evaluation of the Attenuation by Aes-103 of Hypoxia Mediated Decrements in Endurance Exercise Performance". In low oxygen environments, such as high-altitude, some adults may become ill and suffer from acute mountain sickness. Further, all adults will find that exercising becomes much more difficult when compared with exercise at lower altitudes (e.g. sea-level). The purpose of this investigation is to st...
What is the current status of trial NCT01871142?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2013-03. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01871142?
The interventions under investigation include: Placebo (DRUG), Aes-103 (DRUG).
Who is sponsoring clinical trial NCT01871142?
This trial is sponsored by Colorado State University, which has 94 total clinical trials registered on ClinicalTrials.gov.
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