Safety Study of SRX251 Capsules in Healthy Female Volunteers (AVN001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00461370
Recruitment Status : Completed
First Posted : April 18, 2007
Last Update Posted : March 13, 2008
Information provided by:
Azevan Pharmaceuticals

Brief Summary:
The purpose of this study is to determine the safety of SRX251 when given orally. The amount of SRX251 in the blood will also be measured. Healthy women, ages 18-50 years who have been surgically sterilized by tubal ligation, will be enrolled in this study.

Condition or disease Intervention/treatment Phase
Healthy Drug: SRX251 Phase 1

Detailed Description:

Vasopressin appears to be a key mediating factor in menstrual pain. This position stems from findings that the hormone, arginine vasopressin (AVP), causes constriction of uterine blood vessels which in turn produces congestion of the uterus resulting in dysmenorrhea. Prior to menses, blood vessels in the uterine wall become engorged with blood. Elevated concentrations of vasopressin acting through V1a receptors cause constriction of both uterine and vascular smooth muscle, contributing to the discomfort and pain of primary dysmenorrhea. Consequently, blockade of these receptors with a selective V1a receptor antagonist would be expected to provide therapeutic benefits to women with primary dysmenorrhea.

SRX251 is a new chemical entity with potent V1a receptor antagonist properties, and an acceptable safety profile as demonstrated in preclinical studies. This study is intended to evaluate the safety and pharmacokinetic profile of a single oral dose of SRX251 in healthy human female volunteers in preparation for further studies of the safety and pharmacological activity in the amelioration of pain associated with primary dysmenorrhea.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase I, Double-Blind, Placebo-Controlled, Ascending, Single-Dose, Safety, Tolerability and Pharmacokinetic Study of SRX251 Capsules in Healthy Female Volunteers
Study Start Date : April 2007
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Primary Outcome Measures :
  1. safety [ Time Frame: duration of protocol ]

Secondary Outcome Measures :
  1. pharmacokinetics [ Time Frame: duration of protocol ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Females of ≥18 and ≤50 years of age who have a regular menstrual cycle between 24-35 days duration.
  2. Have a body mass index (BMI) of ≥18.5 and ≤30.
  3. In good health as determined by medical history, a baseline physical examination, vital signs, clinical laboratory tests and electrocardiogram (ECG) measurement.
  4. Subject has undergone surgical sterilization by tubal ligation.
  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. Subject is pregnant or nursing.
  2. Subject has undergone surgical sterilization by any method other than tubal ligation (e.g., hysterectomy).
  3. Positive results for HIV, hepatitis B surface antigen or hepatitis C antibody tests at screening.
  4. Positive urine test for drugs of abuse at screening.
  5. Any out-of range laboratory value at screening that has not been reviewed, approved and documented as not clinically significant by the Principal Investigator.
  6. Supine blood pressure, after resting for 5-10 minutes, outside 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 5 minutes apart.
  7. Supine pulse rate, after resting for 5-10 minutes, greater than 100 bpm or lower than 50 bpm on two consecutive measurements taken 5-10 minutes apart.
  8. 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.
  9. Has used any tobacco products in the past 12 months.
  10. A history of significant drug allergy or systemic allergic disease (e.g., urticaria, atopic dermatitis).
  11. 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.
  12. Any clinically significant abnormality on screening 12-lead ECG (e.g., heart block, conduction disorders, ventricular and/or atrial arrhythmias).
  13. 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.
  14. Routine or PRN consumption of medications or herbal supplements that the subject is unable or unwilling to discontinue during the study. Multivitamins may be consumed during the study.
  15. Inability to understand or follow study instructions.
  16. Known allergy or hypersensitivity to the investigational study drug/placebo components.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00461370

United States, New Jersey
Advanced Biomedical Research, Inc.
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Azevan Pharmaceuticals
Principal Investigator: Benno G Roesch, MD Advanced Biomedical Research, Inc. Identifier: NCT00461370     History of Changes
Other Study ID Numbers: AVN001
First Posted: April 18, 2007    Key Record Dates
Last Update Posted: March 13, 2008
Last Verified: August 2007

Keywords provided by Azevan Pharmaceuticals:
Phase 1
safety in healthy volunteers