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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00614016
First Posted: February 13, 2008
Last Update Posted: August 5, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
HemaQuest Pharmaceuticals Inc.
  Purpose
A safety and pharmacokinetic study of a single dose of ST20 in healthy volunteers

Condition Intervention Phase
Healthy Drug: Sodium ST20 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Official Title: A Phase 1, Single-Dose Safety and Pharmacokinetic Study of Sodium ST20 in Healthy Volunteers

Further study details as provided by HemaQuest Pharmaceuticals Inc.:

Primary Outcome Measures:
  • safety, maximum tolerated dose [ Time Frame: specified timepoints in the protocol ]

Secondary Outcome Measures:
  • pharmacokinetics [ Time Frame: specified timepoints in the protocol ]

Enrollment: 40
Study Start Date: January 2008
Study Completion Date: June 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single
8 subjects total (6 active and 2 placebo)
Drug: Sodium ST20
single administration of oral dosage form

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00614016


Locations
United States, Washington
Charles River Clinical Services Northwest, Inc.
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
HemaQuest Pharmaceuticals Inc.
Investigators
Principal Investigator: Robin Downey, MD Charles River Clinical Services Northwest, Inc.
  More Information

Responsible Party: Susan Perrine, MD/ Chief Scientific Officer, HemaQuest Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00614016     History of Changes
Other Study ID Numbers: HQP 2007-001
First Submitted: January 18, 2008
First Posted: February 13, 2008
Last Update Posted: August 5, 2008
Last Verified: August 2008

Keywords provided by HemaQuest Pharmaceuticals Inc.:
healthy volunteers