A Phase 1, Single-Dose Safety and Pharmacokinetic Study of Sodium ST20 in Healthy Volunteers
This study has been completed.
Information provided by:
HemaQuest Pharmaceuticals Inc.
First received: January 18, 2008
Last updated: August 1, 2008
Last verified: August 2008
A safety and pharmacokinetic study of a single dose of ST20 in healthy volunteers
Drug: Sodium ST20
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
||A Phase 1, Single-Dose Safety and Pharmacokinetic Study of Sodium ST20 in Healthy Volunteers
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2008 (Final data collection date for primary outcome measure)
8 subjects total (6 active and 2 placebo)
Drug: Sodium ST20
single administration of oral dosage form
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.
|Ages Eligible for Study:
||18 Years to 45 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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
|Charles River Clinical Services Northwest, Inc.
|Tacoma, Washington, United States, 98418 |
HemaQuest Pharmaceuticals Inc.
||Robin Downey, MD
||Charles River Clinical Services Northwest, Inc.
No publications provided
||Susan Perrine, MD/ Chief Scientific Officer, HemaQuest Pharmaceuticals, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 18, 2008
||August 1, 2008
||United States: Food and Drug Administration
Keywords provided by HemaQuest Pharmaceuticals Inc.:
ClinicalTrials.gov processed this record on October 23, 2014