Trial Outcomes & Findings for Evaluation of the Attenuation by Aes-103 of Hypoxia Mediated Decrements in Endurance Exercise Performance (NCT NCT01871142)
NCT ID: NCT01871142
Last Updated: 2014-10-24
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
The time trial will begin after 1 hour after consumption of the intervention or placebo under normoxic or hypoxic conditions.
Results posted on
2014-10-24
Participant Flow
Participant milestones
| Measure |
Randomized Crossover Assignment
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.
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|---|---|
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Overall Study
STARTED
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12
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Overall Study
Received Placebo + Normoixa
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11
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Overall Study
Received Placebo + Hypoxia
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12
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Overall Study
Received 1000mg Aes 103+ Hypoxia
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11
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Overall Study
Received 3000mg Aes-103 + Hypoxia
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12
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Overall Study
COMPLETED
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11
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Randomized Crossover Assignment
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.
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|---|---|
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Overall Study
Adverse Event
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1
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Baseline Characteristics
Evaluation of the Attenuation by Aes-103 of Hypoxia Mediated Decrements in Endurance Exercise Performance
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=12 Participants
All enrolled participant baseline data
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|---|---|
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Age, Continuous
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27 years
STANDARD_DEVIATION 6 • n=5 Participants
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Sex: Female, Male
Female
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0 Participants
n=5 Participants
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Sex: Female, Male
Male
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12 Participants
n=5 Participants
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Region of Enrollment
United States
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12 participants
n=5 Participants
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Height
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1.75 meters
STANDARD_DEVIATION 0.03 • n=5 Participants
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Body Mass (kg)
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74.8 Kilograms
STANDARD_DEVIATION 6 • n=5 Participants
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Body Mass Index (BMI)
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24.3 kg/m^2
STANDARD_DEVIATION 2 • n=5 Participants
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Fat Mass (kg)
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14.1 kilograms
STANDARD_DEVIATION 4 • n=5 Participants
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Lean Mass (kg)
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56.7 kilograms
STANDARD_DEVIATION 5 • n=5 Participants
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Percent Body Fat
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19 Percentage of body fat
STANDARD_DEVIATION 4 • n=5 Participants
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Waist Circumference (cm)
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79.3 centimeters
STANDARD_DEVIATION 5 • n=5 Participants
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Waist-to-Hip Ratio
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79.3 ratio
STANDARD_DEVIATION 0.04 • n=5 Participants
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Maximal oxygen uptake (VO2max (L/min))
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3.96 Liters/minute
STANDARD_DEVIATION 0.06 • n=5 Participants
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VO2max (ml/kg/min)
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53.2 milliliter/kilogram/minute
STANDARD_DEVIATION 8 • n=5 Participants
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Maximal heart rate (HRmax (beats/min))
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187 Beats/minute
STANDARD_DEVIATION 4 • n=5 Participants
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Maximal respiratory exchange ratio (RERmax)
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1.09 VCO2/VO2
STANDARD_DEVIATION 0.02 • n=5 Participants
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PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Palcebo + Normoxia
n=11 Participants
Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Normoxia (21% oxygen)
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Placebo + Hypoxia
n=11 Participants
Randomized crossover assignment for each participant.
Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Hypoxia (15% Oxygen)
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1000mg Aes-103 + Hypoxia
n=11 Participants
Randomized crossover assignment for each participant.
Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Hypoxia (15% oxygen)
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3000mg Aes-103 + Hypoxia
n=11 Participants
Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Hypoxia (15% oxygen)
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Primary Objective Endurance Exercise Performance
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22.4 minutes
Standard Error 0.7
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24.5 minutes
Standard Error 0.5
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24.0 minutes
Standard Error 0.7
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24.6 minutes
Standard Error 0.6
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SECONDARY outcome
Timeframe: AEs will be monitored at the time of visit and during the follow up period of 7 to 14 days.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.
Outcome measures
| Measure |
Palcebo + Normoxia
n=11 Participants
Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Normoxia (21% oxygen)
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Placebo + Hypoxia
n=12 Participants
Randomized crossover assignment for each participant.
Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Hypoxia (15% Oxygen)
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1000mg Aes-103 + Hypoxia
n=11 Participants
Randomized crossover assignment for each participant.
Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Hypoxia (15% oxygen)
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3000mg Aes-103 + Hypoxia
n=12 Participants
Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Hypoxia (15% oxygen)
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|---|---|---|---|---|
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Secondary Objective Safety and Tolerability
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0 participants
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0 participants
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0 participants
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1 participants
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Adverse Events
Placebo + Normoxia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo + Hypoxia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1000 mg Aes-103 + Hypoxia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hypoxia 3000 mg Aes-103 + Hypoxia
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo + Normoxia
n=11 participants at risk
Participants receiving placebo in normoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Normoxia (21% oxygen)
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Placebo + Hypoxia
n=12 participants at risk
Participants receiving placebo in Hypoxic conditions Randomized crossover assignment for each participant Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Hypoxia (15% Oxygen)
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1000 mg Aes-103 + Hypoxia
n=11 participants at risk
Participants receiving 1000mg Aes-103 in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Hypoxia (15% oxygen)
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Hypoxia 3000 mg Aes-103 + Hypoxia
n=12 participants at risk
Participants receiving 3000mg Aes-103 in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Hypoxia (15% oxygen
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General disorders
Nausea leading to vomiting
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0.00%
0/11 • 1 day
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0.00%
0/12 • 1 day
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0.00%
0/11 • 1 day
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8.3%
1/12 • Number of events 1 • 1 day
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place