Study of SRX246 Capsules in Healthy Adult Volunteers (AVN005)

This study has been completed.
Sponsor:
Information provided by:
Azevan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00910455
First received: May 27, 2009
Last updated: March 16, 2010
Last verified: March 2010
  Purpose

This is the first study of SRX246 in humans, and is being conducted to begin to establish a safety profile of orally administered SRX246.


Condition Intervention Phase
Healthy
Drug: SRX246
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Phase I, Double-Blind, Placebo-Controlled, Ascending, Single-Dose, Safety, Tolerability and Pharmacokinetic Study of SRX246 Capsules in Healthy Adult Volunteers

Further study details as provided by Azevan Pharmaceuticals:

Primary Outcome Measures:
  • To assess safety and tolerability of SRX246 at single doses ranging between 20 and 360 mg [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess Pharmacokinetics of SRX246 at single doses ranging between 20 and 360 mg [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: May 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
Single oral dose of SRX246 capsule
Drug: SRX246
single oral dose of SRX246 capsule
Placebo Comparator: Placebo
Single oral dose of placebo capsule
Drug: Placebo
Single oral dose of placebo capsule

Detailed Description:

This protocol represents the first in human study of SRX246, and is being conducted to begin to establish a safety profile, and collect human tolerability and pharmacokinetic data of orally administered SRX246.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males and non-pregnant, non-lactating females of non-childbearing potential. Female patients should be either post-menopausal or surgically sterile.
  2. Age ≥18 and ≤55 years.
  3. Body mass index (BMI) of 18.5 to 34.0 kg/m2, inclusive, and a total body weight of >50kg (110 pounds).
  4. In good health as determined by medical history, a baseline physical examination, vital signs, clinical laboratory tests and electrocardiogram (ECG) measurement.
  5. Subject is willing and able to sign written informed consent prior to receipt of any study medication or beginning study procedures.
  6. Subject is willing and able to follow instructions, comply with the protocol requirements and make all required study visits.

Exclusion Criteria:

  1. Pregnant or lactating females, or females of childbearing potential.
  2. Subject is positive for HIV, hepatitis B surface antigen or hepatitis C antibody tests at screening.
  3. Subject with a positive urine test for drugs of abuse or alcohol at screening or at admission to the clinic on study Day -1.
  4. Evidence of any out-of range laboratory value at screening that has not been reviewed, approved and documented as not clinically significant by the Principal Investigator.
  5. Subject who has resting supine blood pressure outside of a systolic blood pressure range of 90-140 mmHg or a diastolic blood pressure outside a range of 50-90 mmHg on two consecutive measurements taken up to 10 minutes apart.
  6. Subject who has resting supine pulse rate greater than 100 bpm or less than 50 bpm on two consecutive measurements taken up to 10 minutes apart.
  7. Subject has taken any alcohol within 48 hours of ANY study-related activities AND cannot abstain from drinking alcohol during the entire duration of the subject's study participation.
  8. Subject has used any tobacco products in the past 12 months.
  9. A history of significant drug allergy or systemic allergic disease (e.g., urticaria, atopic dermatitis).
  10. 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.
  11. Any clinically significant abnormality on screening 12-lead ECG (e.g., heart block, conduction disorders, ventricular and/or atrial arrhythmias).
  12. 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 or the Physician Sub-Investigator, would make the subject unsuitable for the study or put them at additional risk.
  13. Routine or PRN consumption of medications or herbal supplements that the subject is unable or unwilling to discontinue during the study.
  14. Inability to understand or follow study instructions.
  15. Treatment with an investigational drug within 30 days preceding the first dose of study medication.
  16. Known allergy or hypersensitivity to the investigational study drug/placebo components.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00910455

Locations
United States, New Jersey
Advanced Biomedical Research
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Azevan Pharmaceuticals
Investigators
Principal Investigator: Benno G Roesch, MD Advanced Biomedical Research
  More Information

No publications provided

Responsible Party: Neal G. Simon, Ph.D., CEO, Azevan Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00910455     History of Changes
Other Study ID Numbers: AVN005
Study First Received: May 27, 2009
Last Updated: March 16, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Azevan Pharmaceuticals:
Phase 1
Safety
Tolerability
Pharmacokinetics

ClinicalTrials.gov processed this record on April 17, 2014