Clinical trial NCT00614016: A Phase 1, Single-Dose Safety and Pharmacokinetic Study of Sodium ST20 in Healthy Volunteers
Official title: A Phase 1, Single-Dose Safety and Pharmacokinetic Study of Sodium ST20 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy volunteers
Lead sponsor: HemaQuest Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: A safety and pharmacokinetic study of a single dose of ST20 in healthy volunteers

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: safety, maximum tolerated dose
timeFrame: specified timepoints in the protocol
Secondary outcomes:
measure: pharmacokinetics
timeFrame: specified timepoints in the protocol
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Charles River Clinical Services Northwest, Inc.
state: Washington
Study officials:
affiliation: Charles River Clinical Services Northwest, Inc.
name: Robin Downey, MD
role: PRINCIPAL_INVESTIGATOR
References: