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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Sodium ST20

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Washington
    • Tacoma, Washington, United States, 98418
      • Charles River Clinical Services Northwest, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single; 8 subjects total (6 active and 2 placebo)	Drug: Sodium ST20; single administration of oral dosage form

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
pharmacokinetics	specified timepoints in the protocol

Collaborators and Investigators

• Sponsor: HemaQuest Pharmaceuticals Inc.
• Investigators: Principal Investigator: Robin Downey, MD, Charles River Clinical Services Northwest, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: January 18, 2008
• First Submitted That Met QC Criteria: February 11, 2008
• First Posted (Estimate): February 13, 2008

Study Record Updates

• Last Update Posted (Estimate): August 5, 2008
• Last Update Submitted That Met QC Criteria: August 1, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: healthy volunteers
• Other Study ID Numbers: HQP 2007-001