- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00532467
Multiple Dose Safety Study of SRX251 Capsules in Healthy Volunteers
March 11, 2008 updated by: Azevan Pharmaceuticals
Phase I, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic Study of SRX251 Capsules in Healthy Volunteers
This study is the second study to evaluate SRX251 in healthy volunteers and it represents the first multiple dose study.
The primary objective of this study is to evaluate the safety and tolerability of escalating multiple oral doses of SRX251 capsules for 5 days in healthy adult volunteers.
Levels of the drug in blood plasma will also be determined.
Study Overview
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Advanced Biomedical Research, Inc.
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy subjects between the ages of 18 and 55 years, inclusive. Subjects will be males or non-pregnant, non lactating females of non-childbearing potential.
- Body mass index (BMI) of 18.5 to 34.0 kg/m2, inclusive, and a total body weight of >50kg (110 pounds).
- In good health as determined by medical history, a baseline physical examination, vital signs, clinical laboratory tests and electrocardiogram (ECG) measurement.
- Subject is willing and able to sign written informed consent prior to beginning study procedures.
- Subject is willing and able to follow instructions, comply with the protocol requirements and make all required study visits.
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but not excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Pregnant or lactating females, or females of childbearing potential, defined as females who are not postmenopausal (postmenopausal females are defined as females who are 45 to 55 years of age and must be amenorrheic for at least 1 year PLUS have a serum FSH level within the laboratory's reference range for postmenopausal women) and females who have not had a hysterectomy and/or bilateral oophorectomy and/or tubal ligation.
- Male subjects not willing to either abstain from sexual intercourse, or use one of the following methods of contraception from the first dose of trial medication until completion of follow-up procedures. Male subjects, without a vasectomy, must use a condom and be instructed that their female partner should use another form of contraception such as an IUD, spermicidal foam/gel/film/cream/suppository, diaphragm with spermicide, oral contraceptive, injectable progesterone, subdermal implant or a tubal ligation if the female partner could become pregnant from the time of the first dose of trial medication until completion of follow-up procedures.
- Subject is positive for HIV, hepatitis B surface antigen or hepatitis C antibody tests at screening.
- A general medical or psychological condition or behavior, including current substance dependence or abuse that, in the opinion of the investigator, might not permit the subject to complete the study or sign the informed consent.
- Any other condition or clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening that, in the opinion of the Principal Investigator, would make the subject unsuitable for the study or put them at additional risk.
- Inability to understand or follow study instructions.
- Known allergy or hypersensitivity to the investigational study drug/placebo components.
- Treatment with an investigational drug within 30 days preceding the first does of study medication.
- Blood donation of approximately 500 mL or more within 56 days prior to dosing.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
safety and tolerability
Time Frame: duration of protocol
|
duration of protocol
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pharmacokinetics
Time Frame: according to protocol
|
according to protocol
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Benno G Roesch, MD, Advanced Biomedical Research, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
February 1, 2008
Study Completion (Actual)
February 1, 2008
Study Registration Dates
First Submitted
September 18, 2007
First Submitted That Met QC Criteria
September 19, 2007
First Posted (Estimate)
September 20, 2007
Study Record Updates
Last Update Posted (Estimate)
March 13, 2008
Last Update Submitted That Met QC Criteria
March 11, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AVN002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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