HypoxiaPhase 1/2NCT01871142
Evaluation of the Attenuation by Aes-103 of Hypoxia Mediated Decrements in Endurance Exercise Performance
A Phase 1/2 study testing Aes-103 in people with Hypoxia, run by Colorado State University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- What is being tested?
- Aes-103
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jun 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State University, Dept. of Health and Exercise Science
Fort Collins, Colorado, 80523-1582
About this study
Official title: Double-Blind, Placebo Controlled Evaluation of the Attenuation by Aes-103 of Hypoxia Mediated Decrements in Endurance Exercise Performance in Healthy Adult Humans
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.
Read the 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 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.
Study participants will report to the Human Performance/Clinical Research Laboratory (HPCRL) on 6 separate occasions. On visit 1 study participants will undergo screening (e.g. medical history and 12-lead electrocardiogram and blood pressure at rest and during incremental exercise to volitional exhaustion), and will be instructed to avoid foods and drinks high in 5-HMF (e.g., coffee, malt, barley, dried fruits, and caramel) for at least 3 days before each subsequent visit. Visit 2 will comprise of a habituation visit during which subjects will be given the opportunity to rehearse the exercise test. Visits 3, 4, 5 and 6, will occur in a random order and be almost identical in nature. Study participants will abstain from vigorous physical exercise and alcohol consumption during the 24-hours prior to each visit. In addition, study participants will abstain from all food and beverages, except water, during the 4-hours prior to visits 3, 4, 5 and 6. On arrival subjects will be instrumented for measurement of heart rate, blood pressure and blood oxygen saturation. Following baseline determination subjects will consume either: a placebo, 1000 mg of Aes-103 or 3000 mg of Aes-103. 45 minutes after consumption, participants will enter our environmental chamber, adjusted randomly to either normoxia (21% oxygen) or hypoxia (15% oxygen). The pairing of normoxia/hypoxia and supplement will be as follows: placebo + normoxia, placebo + hypoxia, 1000 mg + hypoxia, and 3000 mg + hypoxia. Participants will remain seated in the environmental chamber for 15 minutes, after which they will complete a standardized warm-up bout of exercise (100 W for 30 minutes) followed by a brief time trial (time taken to cycle 12.5 km (~7.75 miles)). Heart rate, blood pressure and blood oxygen saturation will be recorded every 5 minutes. During exercise, subjective ratings of perceived exertion (Borg Scale) will be recorded every 10 minutes, and at end-exercise.
- Conditions
- Hypoxia
- Being tested
- Placebo, Aes-103
- Keywords
- 5 Hydroxymethyl 2 Furfural, AES103, Exercise
- Medical subject headings
- Hypoxia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Tropicana Pure Premium Orange Juice
100 mL
Aes-103Drug
Also called 5-Hydroxymethyl-2-Furfural (5-HMF)
Single dose of 1000mg Aes-103 dissolved in 100 mL of Tropicana Pure Premium Orange Juice
Aes-103Drug
Also called 5-Hydroxymethyl-2-Furfural (5-HMF)
Single dose of 3000mg Aes-103 dissolved in 100 mL of Tropicana Pure Premium Orange Juice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Placebo; Drug: Aes-103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
To assess the safety and tolerability of single, escalating oral doses of Aes-103 compared with placebo in healthy adult men at rest and during stationary cycle ergometer exercise in normoxia and hypoxia by monitoring adverse events (AEs), electrocardiograms (ECGs), blood pressure, blood oxygen saturation.
Measured: AEs will be monitored at the time of visit and during the follow up period of 7 to 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- AesRx, LLC
- Responsible party
- Principal investigator, Christopher Bell, Colorado State University
- Investigators
- Christopher Bell, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871142
- Sponsor's protocol ID
- 13-4002H
- Status last verified
- Oct 2014
- First submitted
- 29 May 2013
- Last updated
- 24 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo Controlled Evaluation of the Attenuation by Aes-103 of Hypoxia Mediated Decrements in Endurance Exercise Performance in Healthy Adult Humans
- ClinicalTrials.gov ID
- NCT01871142
- Acronym / sponsor ID
- 13-4002H
- Conditions
- Hypoxia
- Keywords
- 5 Hydroxymethyl 2 Furfural, AES103, Exercise
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- AesRx, LLC
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 6 Jun 2013 (estimated)
- Results
- Posted 24 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study participants will report to the Human Performance/Clinical Research Laboratory (HPCRL) on 6 separate occasions. On visit 1 study participants will undergo screening (e.g. medical history and 12-lead electrocardiogram and blood pressure at rest and during incremental exercise to volitional exhaustion), and will be instructed to avoid foods and drinks high in 5-HMF (e.g., coffee, malt, barley, dried fruits, and caramel) for at least 3 days before each subsequent visit. Visit 2 will comprise of a habituation visit during which subjects will be given the opportunity to rehearse the exercise test. Visits 3, 4, 5 and 6, will occur in a random order and be almost identical in nature. Study participants will abstain from vigorous physical exercise and alcohol consumption during the 24-hours prior to each visit. In addition, study participants will abstain from all food and beverages, except water, during the 4-hours prior to visits 3, 4, 5 and 6. On arrival subjects will be instrumented for measurement of heart rate, blood pressure and blood oxygen saturation. Following baseline determination subjects will consume either: a placebo, 1000 mg of Aes-103 or 3000 mg of Aes-103. 45 minutes after consumption, participants will enter our environmental chamber, adjusted randomly to either normoxia (21% oxygen) or hypoxia (15% oxygen). The pairing of normoxia/hypoxia and supplement will be as follows: placebo + normoxia, placebo + hypoxia, 1000 mg + hypoxia, and 3000 mg + hypoxia. Participants will remain seated in the environmental chamber for 15 minutes, after which they will complete a standardized warm-up bout of exercise (100 W for 30 minutes) followed by a brief time trial (time taken to cycle 12.5 km (~7.75 miles)). Heart rate, blood pressure and blood oxygen saturation will be recorded every 5 minutes. During exercise, subjective ratings of perceived exertion (Borg Scale) will be recorded every 10 minutes, and at end-exercise.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Randomized crossover assignment | Experimental | Drug: Placebo, Drug: Aes-103Participants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Tropicana Pure Premium Orange Juice100 mL | Drug | Randomized crossover assignment |
| Aes-103Also: 5-Hydroxymethyl-2-Furfural (5-HMF)Single dose of 1000mg Aes-103 dissolved in 100 mL of Tropicana Pure Premium Orange Juice | Drug | Randomized crossover assignment |
| Aes-103Also: 5-Hydroxymethyl-2-Furfural (5-HMF)Single dose of 3000mg Aes-103 dissolved in 100 mL of Tropicana Pure Premium Orange Juice | Drug | Randomized crossover assignment |
Primary outcome
Primary Objective Endurance Exercise Performance
Time frame: The time trial will begin after 1 hour after consumption of the intervention or placebo under normoxic or hypoxic conditions.
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).
1 secondary outcome
Secondary Objective Safety and Tolerability
Time frame: AEs will be monitored at the time of visit and during the follow up period of 7 to 14 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Department of Health and Exercise Science, Colorado State UniversityLink provided by the sponsor.
- Initial Safety Trial For Treatments Under Investigation In Current StudyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Bell, PhD principal investigator
Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Aes-103 in people with Hypoxia, run by Colorado State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective Endurance Exercise Performance (time frame: The time trial will begin after 1 hour after consumption of the intervention or placebo under normoxic or hypoxic conditions.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2014.