MedDataX Logo

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

NCT ID: NCT00614016

Last Updated: 2008-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

healthy volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

single

8 subjects total (6 active and 2 placebo)

Group Type EXPERIMENTAL

Sodium ST20

Intervention Type DRUG

single administration of oral dosage form

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sodium ST20

single administration of oral dosage form

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

HemaQuest Pharmaceuticals Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

HemaQuest Pharmaceuticals, Inc.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robin Downey, MD

Role: PRINCIPAL_INVESTIGATOR

Charles River Clinical Services Northwest, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Charles River Clinical Services Northwest, Inc.

Tacoma, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HQP 2007-001

Identifier Type: -

Identifier Source: org_study_id