Status:
COMPLETED
Evaluation of the Attenuation by Aes-103 of Hypoxia Mediated Decrements in Endurance Exercise Performance
Lead Sponsor:
Colorado State University
Collaborating Sponsors:
AesRx, LLC
Conditions:
Hypoxia
Eligibility:
MALE
18-40 years
Phase:
PHASE1
PHASE2
Brief 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 co...
Detailed Description
This is a randomized, placebo-controlled, double-blind blind, repeated measures (cross-over) study. Approximately 12 healthy adult men will consume, in a random order, a placebo prior to exercise in n...
Eligibility Criteria
Inclusion
- Be a healthy male volunteer, aged 18-40 years old, body mass index 18-30 kg/m2, inclusive
- Have successfully completed a screening visit consisting of medical history, physical examination, 12-lead ECG, blood pressure, blood oxygen saturation at rest and during incremental exercise to volitional exhaustion (Note: Subjects with abnormal screening values may be eligible if the results are not clinically significant, as judged by the investigator or medical monitor)
- Be able to understand and have provided written informed consent including signature on an informed consent form approved by an institutional review board
- Have provided written authorization for use and disclosure of protected health information
- Agree to abide by the study schedule and dietary restrictions and to return for the required assessments
- Be willing to abstain from foods high in 5-HMF (e.g., coffee, malt, barley, balsamic vinegar, dried fruits,and caramel products) for at least 3 days prior to each dosing
- Be willing and able to repeatedly perform exhaustive cycle ergometer exercise
Exclusion
- Have evidence of clinically significant cardiovascular, respiratory, renal, hepatic, pulmonary, gastrointestinal, hematological, neurological, psychiatric, or other disease that may interfere with the objectives of the study or the safety of the subject, as judged by the investigator in agreement with the sponsor or medical monitor, have been hospitalized in the past 2 years as a result of these conditions, or are receiving pharmacological treatment for these conditions
- Have taken prescription drugs or herbal preparations in the 2 weeks before dosing
- Is currently enrolled in another clinical study for another investigational drug or has taken any other investigational drug within 30 days before the screening visit
- Habitual and/or recent use of recreational drugs, such as cocaine, marijuana, opiates, amphetamines, methamphetamines, benzodiazepines,
- Have taken disulfiram, 4-methylpyrazole, or any other drug that is an inhibitor of alcohol dehydrogenase or aldehyde dehydrogenase within the past 30 days
- Have engaged in strenuous physical activity within 24 hours prior to dosing
- Be considered not suitable for participation in this trial for any reason, as judged by the investigator
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01871142
Start Date
March 1 2013
End Date
June 1 2014
Last Update
October 24 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Colorado State University, Dept. of Health and Exercise Science
Fort Collins, Colorado, United States, 80523-1582