Status:
COMPLETED
Safety and Efficacy of Trans Sodium Crocetinate (TSC) in Enhancing Tissue Oxygen Levels in Healthy Volunteers
Lead Sponsor:
Diffusion Pharmaceuticals Inc
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
Randomized, double-blind, placebo-controlled, pharmacokinetic, pharmacodynamic study. Subjects will be randomized to TSC or placebo to determine the effect of Trans Sodium Crocetinate (TSC) on Transc...
Detailed Description
This is a randomized, double-blind, placebo-controlled, pharmacokinetic, pharmacodynamic study of Trans Sodium Crocetinate (TSC) in healthy volunteers. The primary objective is to determine the effect...
Eligibility Criteria
Inclusion
- Healthy male or female, age 18-50
- Able and willing to lie quietly supine or semi-recumbent for up to 2.5 hours
- Abstinence from exercise, caffeine, alcohol, nicotine, and a heavy meal prior to testing on the day of the Treatment Visit
- Subject is able to communicate effectively with the Investigator and to comply with all study requirements, restrictions, and directions from the study staff
- 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 (e.g. condom and spermicide), during the study and at least 30 days after the last dose of study drug. Females of non-childbearing potential should be surgically sterile or at least one year post-menopausal.
- Males who engage in sexual activity that has the risk of pregnancy must agree to use a double barrier method (e.g. condom and spermicide) and agree not to donate sperm during the study and for at least 90 days after the last dose of study drug
Exclusion
- Allergy to study medication
- Pregnant or breastfeeding
- Current smoker and/or any nicotine use within 4 hours of the start of tcpO2 procedures, to include e-cigarette vaping, snuff, chew, nicotine gum and nicotine patches
- Body Mass Index (BMI) \> 30
- Positive test results for HIV-1/HIV-2 Antibodies, Hepatitis B surface Antigen (HBsAg), or Hepatitis C Antibody (HCVAb)
- 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
- Any skin condition on limbs to be tested that could impair testing (rash, wound, prior radiation therapy, other skin conditions, per Principal Investigator (PI) discretion)
- Known cardiovascular disease, including treated or untreated hypertension
- Significant respiratory disease and/or any other significant medical condition
- Subject has an acute illness (gastrointestinal infection, influenza, or known inflammatory process) at the Treatment Visit
- Urine screen positive for drugs or positive breathalyzer for alcohol (at screening and enrollment)
- Concomitant medications used to treat a diagnosed medical condition
- Subject who, for any reason, is deemed by the Investigator to be unsuitable for the study; or has any condition that would interfere with the evaluation of tissue oxygen measurements or PK of the investigational drug; or is otherwise unable to comply with the protocol
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04808622
Start Date
March 17 2021
End Date
March 25 2021
Last Update
July 11 2023
Active Locations (1)
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1
Altasciences Clinical Kansas Inc
Overland Park, Kansas, United States, 66212