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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

January 18, 2008
August 1, 2008
January 2008
April 2008   (final data collection date for primary outcome measure)
safety, maximum tolerated dose [ Time Frame: specified timepoints in the protocol ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00614016 on ClinicalTrials.gov Archive Site
pharmacokinetics [ Time Frame: specified timepoints in the protocol ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Phase 1, Single-Dose Safety and Pharmacokinetic Study of Sodium ST20 in Healthy Volunteers
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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Healthy
Drug: Sodium ST20
single administration of oral dosage form
Experimental: single
8 subjects total (6 active and 2 placebo)
Intervention: Drug: Sodium ST20
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00614016
HQP 2007-001
No
Susan Perrine, MD/ Chief Scientific Officer, HemaQuest Pharmaceuticals, Inc.
HemaQuest Pharmaceuticals Inc.
Not Provided
Principal Investigator: Robin Downey, MD Charles River Clinical Services Northwest, Inc.
HemaQuest Pharmaceuticals Inc.
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP