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

NCT ID: NCT05036980

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-09
• Study Completion Date: 2022-04-10

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).

Conditions

Healthy Volunteers With Induced Hypoxia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

0.5 mg/kg Trans Sodium Crocetinate

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.

Group Type: EXPERIMENTAL

Trans Sodium Crocetinate

Intervention Type: DRUG

Single IV bolus

1.5 mg/kg Trans Sodium Crocetinate

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.

Group Type: EXPERIMENTAL

Trans Sodium Crocetinate

Intervention Type: DRUG

Single IV bolus

2.5 mg/kg Trans Sodium Crocetinate

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.

Group Type: EXPERIMENTAL

Trans Sodium Crocetinate

Intervention Type: DRUG

Single IV bolus

Interventions

Trans Sodium Crocetinate

Single IV bolus

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy males and females ages 18-40

2. Non-smoking

3. Able to provide informed consent and agree to adhere to all study visits and requirements.

4. 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.

5. 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

1. Allergy to study medication

2. Pregnant or breast feeding

3. Received investigational medicine (IMP) within past 30 days

4. VO2 max < 35 mL/kg/min (male), < 30 mL/kg/min (female) at screening

5. Abnormal pulmonary function testing at screening

6. Surgery or hospitalization in past 3 months determined by the PI to be clinically relevant

7. History of ongoing alcohol or substance abuse

8. Known cardiovascular disease, including treated or untreated hypertension

9. Respiratory disease and/or any other significant medical condition, including psychiatric disorders

10. Clinically significant abnormality on ECG per PI discretion

11. Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to screening

12. Plasma donation within 7 days prior to screening

13. Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to screening

14. History of smoking

15. Urine screen positive for drugs or positive breathalyzer for alcohol (at screening and Treatment Visit Day 1)

16. History of seizures

17. Previous pneumothorax or pneumomediastinum

18. Hypo/Hyperglycemia

19. Diabetes

20. Regularly taking medications which may alter heart rate, blood pressure or cardiac output

21. Previous history of middle ear equalization problems at discretion of PI

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Diffusion Pharmaceuticals Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

200-302

Identifier Type: -

Identifier Source: org_study_id