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Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Trans Sodium Crocetinate in Healthy Volunteers Exercising at Altitude

Primary Purpose

Healthy Volunteers With Induced Hypoxia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Trans Sodium Crocetinate

About this trial

This is an interventional treatment trial for Healthy Volunteers With Induced Hypoxia

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy males and females ages 18-40
Non-smoking
Able to provide informed consent and agree to adhere to all study visits and requirements.
Females of childbearing potential must have a negative blood pregnancy test at screening and agree to use one of the accepted contraceptive regimens, or a double method of birth control during the study and at least 30 days after the last dose of study drug.
Males who engage in sexual activity that has the risk of pregnancy must agree to use a double barrier method and agree not to donate sperm during the study and for at least 90 days after the last dose of study drug

Exclusion Criteria:

Allergy to study medication
Pregnant or breast feeding
Received investigational medicine (IMP) within past 30 days
VO2 max < 35 mL/kg/min (male), < 30 mL/kg/min (female) at screening
Abnormal pulmonary function testing at screening
Surgery or hospitalization in past 3 months determined by the PI to be clinically relevant
History of ongoing alcohol or substance abuse
Known cardiovascular disease, including treated or untreated hypertension
Respiratory disease and/or any other significant medical condition, including psychiatric disorders
Clinically significant abnormality on ECG per PI discretion
Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to screening
Plasma donation within 7 days prior to screening
Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to screening
History of smoking
Urine screen positive for drugs or positive breathalyzer for alcohol (at screening and Treatment Visit Day 1)
History of seizures
Previous pneumothorax or pneumomediastinum
Hypo/Hyperglycemia
Diabetes
Regularly taking medications which may alter heart rate, blood pressure or cardiac output
Previous history of middle ear equalization problems at discretion of PI

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

0.5 mg/kg Trans Sodium Crocetinate

1.5 mg/kg Trans Sodium Crocetinate

2.5 mg/kg Trans Sodium Crocetinate

Arm Description

Subjects will receive a single IV bolus dose of 0.5 mg/kg TSC. Subjects will also receive a single IV dose of normal saline as placebo, thereby serving as their own control.

Subjects will receive a single IV bolus dose of 1.5 mg/kg TSC. Subjects will also receive a single IV dose of normal saline as placebo, thereby serving as their own control.

Subjects will receive a single IV bolus dose of 2.5 mg/kg TSC. Subjects will also receive a single IV dose of normal saline as placebo, thereby serving as their own control.

Outcomes

Primary Outcome Measures

Sequence matched median PaO2 per dose cohort comparing TSC vs PBO

Comparison of partial pressure of oxygen (PaO2) at altitude between control and experimental exposures

Sequence matched median VO2 per dose cohort comparing TSC vs PBO

Comparison of maximal oxygen consumption (VO2 max) at altitude between control and experimental exposures

Secondary Outcome Measures

Effect of TSC on Median Oxygen Saturation

Comparison of oxygen saturation (SpO2) between the control and experimental exposures

Effect of TSC on Median Serum Lactate Concentration

Comparison of lactate between the control and experimental exposures

Full Information

NCT ID

NCT05036980

First Posted

July 30, 2021

Last Updated

April 12, 2022

Sponsor

Diffusion Pharmaceuticals Inc

1. Study Identification

Unique Protocol Identification Number

NCT05036980

Brief Title

Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Trans Sodium Crocetinate in Healthy Volunteers Exercising at Altitude

Official Title

Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Trans Sodium Crocetinate in Healthy Volunteers Exercising at Altitude

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

November 9, 2021 (Actual)

Primary Completion Date

April 8, 2022 (Actual)

Study Completion Date

April 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Diffusion Pharmaceuticals Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Volunteers With Induced Hypoxia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.5 mg/kg Trans Sodium Crocetinate

Arm Type

Experimental

Arm Description

Subjects will receive a single IV bolus dose of 0.5 mg/kg TSC. Subjects will also receive a single IV dose of normal saline as placebo, thereby serving as their own control.

Arm Title

1.5 mg/kg Trans Sodium Crocetinate

Arm Type

Experimental

Arm Description

Subjects will receive a single IV bolus dose of 1.5 mg/kg TSC. Subjects will also receive a single IV dose of normal saline as placebo, thereby serving as their own control.

Arm Title

2.5 mg/kg Trans Sodium Crocetinate

Arm Type

Experimental

Arm Description

Subjects will receive a single IV bolus dose of 2.5 mg/kg TSC. Subjects will also receive a single IV dose of normal saline as placebo, thereby serving as their own control.

Intervention Type

Drug

Intervention Name(s)

Trans Sodium Crocetinate

Intervention Description

Single IV bolus

Primary Outcome Measure Information:

Title

Sequence matched median PaO2 per dose cohort comparing TSC vs PBO

Description

Comparison of partial pressure of oxygen (PaO2) at altitude between control and experimental exposures

Time Frame

Up to 10 ± 1 minutes after final VO2 max

Title

Sequence matched median VO2 per dose cohort comparing TSC vs PBO

Description

Comparison of maximal oxygen consumption (VO2 max) at altitude between control and experimental exposures

Time Frame

Up to 33 minutes (achievement of peak wattage)

Secondary Outcome Measure Information:

Title

Effect of TSC on Median Oxygen Saturation

Description

Comparison of oxygen saturation (SpO2) between the control and experimental exposures

Time Frame

Up to 33 minutes (achievement of peak wattage)

Title

Effect of TSC on Median Serum Lactate Concentration

Description

Comparison of lactate between the control and experimental exposures

Time Frame

Up to 33 minutes (achievement of peak wattage)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy males and females ages 18-40 Non-smoking Able to provide informed consent and agree to adhere to all study visits and requirements. Females of childbearing potential must have a negative blood pregnancy test at screening and agree to use one of the accepted contraceptive regimens, or a double method of birth control during the study and at least 30 days after the last dose of study drug. Males who engage in sexual activity that has the risk of pregnancy must agree to use a double barrier method and agree not to donate sperm during the study and for at least 90 days after the last dose of study drug Exclusion Criteria: Allergy to study medication Pregnant or breast feeding Received investigational medicine (IMP) within past 30 days VO2 max < 35 mL/kg/min (male), < 30 mL/kg/min (female) at screening Abnormal pulmonary function testing at screening Surgery or hospitalization in past 3 months determined by the PI to be clinically relevant History of ongoing alcohol or substance abuse Known cardiovascular disease, including treated or untreated hypertension Respiratory disease and/or any other significant medical condition, including psychiatric disorders Clinically significant abnormality on ECG per PI discretion Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to screening Plasma donation within 7 days prior to screening Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to screening History of smoking Urine screen positive for drugs or positive breathalyzer for alcohol (at screening and Treatment Visit Day 1) History of seizures Previous pneumothorax or pneumomediastinum Hypo/Hyperglycemia Diabetes Regularly taking medications which may alter heart rate, blood pressure or cardiac output Previous history of middle ear equalization problems at discretion of PI

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

22710

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Trans Sodium Crocetinate in Healthy Volunteers Exercising at Altitude

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