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NCT05036980 · ClinicalTrials.gov registry record · Phase 1
Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Trans Sodium Crocetinate in Healthy Volunteers Exercising at Altitude
A Phase 1 study of Healthy Volunteers With Induced Hypoxia, sponsored by Diffusion Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05036980: Completed Phase 1 study of Healthy Volunteers With Induced Hypoxia, sponsored by Diffusion Pharmaceuticals.
NCT05036980 is a Phase 1 study of Healthy Volunteers With Induced Hypoxia that has completed, run by Diffusion Pharmaceuticals. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05036980, a Phase 1 study of Healthy Volunteers With Induced Hypoxia, has completed, sponsored by Diffusion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, placebo-controlled, crossover study of Trans Sodium Crocetinate (TSC) in healthy volunteers, age 18-40 (inclusive), exercising at altitude. The primary objective is to determine the effect of (TSC) on partial pressure of oxygen (PaO2) and maximal oxygen consumption (VO2 max); the secondary objective is to assess the effect of TSC on oxygen saturation (SpO2).
Primary Outcome
Comparison of partial pressure of oxygen (PaO2) at altitude between control and experimental exposures
Conditions Studied
Interventions
- DRUG Trans Sodium Crocetinate
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-11-09 |
| Est. Completion | 2022-04-10 |
| Phase | Phase 1 |
What the finished NCT05036980 record still lists
NCT05036980 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Healthy Volunteers With Induced Hypoxia appearing as the primary indexed condition, and to 1 intervention - of which Trans Sodium Crocetinate is the first listed.
NCT05036980 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05036980 about?
NCT05036980 is a clinical study titled "Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Trans Sodium Crocetinate in Healthy Volunteers Exercising at Altitude". This is a randomized, placebo-controlled, crossover study of Trans Sodium Crocetinate (TSC) in healthy volunteers, age 18-40 (inclusive), exercising at altitude. The primary objective is to determine the effect of (TSC) on partial pressure of oxygen (PaO2) and maximal oxygen consumption (VO2 max); t...
What is the current status of trial NCT05036980?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2021-11-09. Estimated completion is 2022-04-10.
What conditions does trial NCT05036980 study?
This clinical trial studies the following conditions: Healthy Volunteers With Induced Hypoxia.
What interventions are being tested in trial NCT05036980?
The interventions under investigation include: Trans Sodium Crocetinate (DRUG).
Who is sponsoring clinical trial NCT05036980?
This trial is sponsored by Diffusion Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05036980 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05036980's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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