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

NCT00614016 | Completed Phase 1

• 1 other identifier: HQP 2007-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

healthy volunteers

Outcome Measures

Primary Outcomes (1)

• safety, maximum tolerated dose

  specified timepoints in the protocol

Secondary Outcomes (1)

• pharmacokinetics

  specified timepoints in the protocol

Study Arms (1)

single

EXPERIMENTAL

8 subjects total (6 active and 2 placebo)

Drug: Sodium ST20

Interventions

Sodium ST20 DRUG

single administration of oral dosage form

single

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HemaQuest Pharmaceuticals Inc.: lead

Study Sites (1)

Charles River Clinical Services Northwest, Inc.

Tacoma, Washington, 98418, United States

Location

Study Officials

• Robin Downey, MD

  Charles River Clinical Services Northwest, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 18, 2008
• First Posted: February 13, 2008
• Study Start: January 1, 2008
• Primary Completion: April 1, 2008
• Study Completion: June 1, 2008
• Last Updated: August 5, 2008

Record last verified: 2008-08

Locations

US (1)