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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 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. The trial reports 1 study location across 1 state.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05036980
The ClinicalTrials.gov registry entry for NCT05036980 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Diffusion Pharmaceuticals, which has 8 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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