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

Sponsored by:	HemaQuest Pharmaceuticals Inc.
Information provided by:	HemaQuest Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00614016

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: Sodium ST20	Phase I

MedlinePlus related topics: Dietary Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety Study
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
single: Experimental 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

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

Responsible Party:	HemaQuest Pharmaceuticals, Inc. ( Susan Perrine, MD/ Chief Scientific Officer )
Study ID Numbers:	HQP 2007-001
Study First Received:	January 18, 2008
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00614016
Health Authority:	United States: Food and Drug Administration

Keywords provided by HemaQuest Pharmaceuticals Inc.:

healthy volunteers

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 14, 2009