Evaluation of the Attenuation by Aes-103 of Hypoxia Mediated Decrements in Endurance Exercise Performance

NCT01871142 | Completed Phase 1 Results

• 1 other identifier: 13-4002H
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hypoxia

Keywords

5 Hydroxymethyl 2 Furfural; AES103; Exercise

Outcome Measures

Primary Outcomes (1)

• Primary Objective Endurance Exercise Performance

  To quantify endurance exercise performance (time trial performance during stationary cycle ergometer exercise) in healthy adult men in four conditions: normoxia (normal oxygen; fraction of inspired oxygen = 0.21) following oral placebo consumption, hypoxia (low oxygen; fraction of inspired oxygen = 0.15) following oral placebo consumption, hypoxia following oral consumption Aes-103 (1000 mg) and hypoxia following oral consumption Aes-103 (3000 mg).

  The time trial will begin after 1 hour after consumption of the intervention or placebo under normoxic or hypoxic conditions.

Secondary Outcomes (1)

• Secondary Objective Safety and Tolerability

  AEs will be monitored at the time of visit and during the follow up period of 7 to 14 days.

Study Arms (1)

Randomized crossover assignment

EXPERIMENTAL

Participants will receive, in a random order, a placebo prior to exercise in normoxia, a placebo prior to exercise in hypoxia, 1000 mg of Aes-103 prior to exercise in hypoxia, and 3000 mg of Aes-103 prior to exercise in hypoxia. Each intervention is separated by a 7 day washout period.

Drug: Placebo; Drug: Aes-103

Interventions

Placebo DRUG

100 mL

Also known as: Tropicana Pure Premium Orange Juice

Randomized crossover assignment

Aes-103 DRUG

Single dose of 1000mg Aes-103 dissolved in 100 mL of Tropicana Pure Premium Orange Juice

Also known as: 5-Hydroxymethyl-2-Furfural (5-HMF)

Randomized crossover assignment

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Colorado State University: lead
• AesRx, LLC: collaborator

Study Sites (1)

Colorado State University, Dept. of Health and Exercise Science

Fort Collins, Colorado, 80523-1582, United States

Location

Related Links

• Department of Health and Exercise Science, Colorado State University
• Initial Safety Trial For Treatments Under Investigation In Current Study

MeSH Terms

Conditions

Hypoxia; Motor Activity

Interventions

5-hydroxymethylfurfural

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Christopher Bell, Ph.D.
• Organization: Colorado State University

christopher.bell@colostate.edu

(970) 491-7522

Study Officials

• Christopher Bell, PhD

  Colorado State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 6, 2013
• Study Start: March 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2014
• Last Updated: October 24, 2014
• Results First Posted: October 24, 2014

Record last verified: 2014-10

Locations

US (1)