A Phase 1, Single-Dose Safety and Pharmacokinetic Study of Sodium ST20 in Healthy Volunteers

Study Overview
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Brief Summary
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A safety and pharmacokinetic study of a single dose of ST20 in healthy volunteers

Detailed Description
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A Phase 1 study in healthy volunteers to assess the safety and pharmacokinetics of ST20 after oral administration of a single-dose. In addition, a comparison of the pharmacokinetics and exposure of a single dose of ST20 under fasting and non-fasting conditions will be assessed.

Official Title
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A Phase 1, Single-Dose Safety and Pharmacokinetic Study of Sodium ST20 in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Sodium ST20


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be a healthy male or female Be between the ages of 18 and 45 years old, inclusive Be able and willing to give informed consent Be able to comply with all study procedures If female, not be pregnant, including negative serum pregnancy test If female, must not be of childbearing potential or must agree to use one or more of the following forms of contraception during screening and throughout the study: hormonal (i.e., oral, transdermal, implant or injection); double barrier (i.e., condom, diaphragm with spermicide); intrauterine device (IUD); vasectomized partner (six months minimum); or abstinence. Male subjects must also agree to use one or more of the above forms of birth control for either themselves or their partner, as appropriate throughout the course of the study Must not be receiving prescription medication within the 2 weeks before administration of the test dose, except for multivitamins or contraception Have white blood cell count, hemoglobin, hematocrit and platelet count within normal range for the testing facility Must have serum chemistry values and urinalysis values within the limits of normal for the testing facility Must have coagulation parameters within the limits of normal for the testing facility Must have a negative urine test for substances of abuse including marijuana, cocaine, cocaine derivatives, opiates and methadone Exclusion Criteria: Have clinically significant vital signs Have any clinically significant laboratory value (CBC, serum chemistry, or urinalysis) Have made a blood donation of 500mL within the 2 months before administration of study medication Have received a blood transfusion within the 3 months before administration of study medication Have an acute febrile illness or upper respiratory tract illness within 72 hours prior to administration of study medication Have received another investigational agent within the 4 weeks before administration of test drug Have received any other investigational agent during this study Have any acute or chronic disease (e.g., history of hepatitis or HIV-1) Have cardiac disease including congestive heart failure or arrhythmia Have a history of central nervous system disease, such as seizures Be breast feeding a child Have been a smoker in the past 12 months Have Body Mass Index (BMI) > 33 kg/m2

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single<br>8 subjects total (6 active and 2 placebo) | Drug: Sodium ST20<br>* single administration of oral dosage form<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety, maximum tolerated dose |  | specified timepoints in the protocol | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetics |  | specified timepoints in the protocol | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy volunteers