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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:
Information provided by:
HemaQuest Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00614016
First received: January 18, 2008
Last updated: August 1, 2008
Last verified: August 2008
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pharmacokinetics [ Time Frame: specified timepoints in the protocol ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 18, 2008
Last Updated: August 1, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by HemaQuest Pharmaceuticals Inc.:
healthy volunteers

ClinicalTrials.gov processed this record on November 24, 2014