Trial · NCT01871142

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

NCT01871142, Phase 1, Phase 2, Completed, Colorado State University; results first posted 2014-10-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluation of the Attenuation by Aes-103 of Hypoxia Mediated Decrements in Endurance Exercise Performance. Trials, record NCT01871142. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01871142

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Evaluation of the Attenuation by Aes-103 of Hypoxia Mediated Decrements in Endurance Exercise Performance
NCT number: NCT01871142
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 12 participants, actual
Lead sponsor: Colorado State University
Conditions: Hypoxia
Interventions: Placebo, Aes-103, Aes-103
First posted: 2013-06-06
Last updated: 2014-10-24
Results first posted: 2014-10-24

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Primary Objective Endurance Exercise Performance	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).
Secondary	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.	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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Primary Objective Endurance Exercise Performance	The time trial will begin after 1 hour after consumption of the intervention or placebo under normoxic or hypoxic conditions.		minutes	MEAN
SECONDARY	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.		participants	NUMBER

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Primary Objective Endurance Exercise Performance	Palcebo + Normoxia	22.4	Standard Error 0.7	minutes
Primary Objective Endurance Exercise Performance	Placebo + Hypoxia	24.5	Standard Error 0.5	minutes
Primary Objective Endurance Exercise Performance	1000mg Aes-103 + Hypoxia	24.0	Standard Error 0.7	minutes
Primary Objective Endurance Exercise Performance	3000mg Aes-103 + Hypoxia	24.6	Standard Error 0.6	minutes
Secondary Objective Safety and Tolerability	Placebo + Normoxia	0		participants
Secondary Objective Safety and Tolerability	Placebo + Hypoxia	0		participants
Secondary Objective Safety and Tolerability	1000mg Aes-103 + Hypoxia	0		participants
Secondary Objective Safety and Tolerability	3000mg Aes-103 + Hypoxia	1		participants

Source ClinicalTrials.gov

Participant flow7

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Randomized Crossover Assignment	12
Overall Study	Received Placebo + Normoixa	Randomized Crossover Assignment	11
Overall Study	Received Placebo + Hypoxia	Randomized Crossover Assignment	12
Overall Study	Received 1000mg Aes 103+ Hypoxia	Randomized Crossover Assignment	11
Overall Study	Received 3000mg Aes-103 + Hypoxia	Randomized Crossover Assignment	12
Overall Study	COMPLETED	Randomized Crossover Assignment	11
Overall Study	NOT COMPLETED	Randomized Crossover Assignment	1

Source ClinicalTrials.gov

Adverse events4

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea leading to vomiting	General disorders	Placebo + Normoxia	0	11	0
other	Nausea leading to vomiting	General disorders	Placebo + Hypoxia	0	12	0
other	Nausea leading to vomiting	General disorders	1000 mg Aes-103 + Hypoxia	0	11	0
other	Nausea leading to vomiting	General disorders	Hypoxia 3000 mg Aes-103 + Hypoxia	1	12	1

Source ClinicalTrials.gov

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo + Normoxia
Total, all-cause mortality	Placebo + Hypoxia
Total, all-cause mortality	1000 mg Aes-103 + Hypoxia
Total, all-cause mortality	Hypoxia 3000 mg Aes-103 + Hypoxia
Total, other adverse events	Placebo + Normoxia	0	11
Total, other adverse events	Placebo + Hypoxia	0	12
Total, other adverse events	1000 mg Aes-103 + Hypoxia	0	11
Total, other adverse events	Hypoxia 3000 mg Aes-103 + Hypoxia	1	12
Total, serious adverse events	Placebo + Normoxia	0	11
Total, serious adverse events	Placebo + Hypoxia	0	12

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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GET https://conductscience.org/api/trials/v1/NCT01871142/registered

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