Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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).

Interventions

  • DRUG Trans Sodium Crocetinate

Study Locations (1)

North Carolina

  • Duke University Medical Center - Durham

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2021-11-09
Est. Completion 2022-04-10
Phase Phase 1

Sponsor

Diffusion Pharmaceuticals

8 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.