Healthy Volunteers With Induced Hypoxia
Conditions
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).
Interventions
Single IV bolus
Sponsors
Diffusion Pharmaceuticals Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sequence matched median PaO2 per dose cohort comparing TSC vs PBO | Up to 10 ± 1 minutes after final VO2 max | 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 | Up to 33 minutes (achievement of peak wattage) | Comparison of maximal oxygen consumption (VO2 max) at altitude between control and experimental exposures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of TSC on Median Serum Lactate Concentration | Up to 33 minutes (achievement of peak wattage) | Comparison of lactate between the control and experimental exposures |
| Effect of TSC on Median Oxygen Saturation | Up to 33 minutes (achievement of peak wattage) | Comparison of oxygen saturation (SpO2) between the control and experimental exposures |
Countries
United States
Outcome results
None listed