Safety Study of SRX251 Capsules in Healthy Female Volunteers (AVN001)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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|
- safety [ Time Frame: duration of protocol ] [ Designated as safety issue: Yes ]
- pharmacokinetics [ Time Frame: duration of protocol ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Study Completion Date:||August 2007|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00461370
|United States, New Jersey|
|Advanced Biomedical Research, Inc.|
|Hackensack, New Jersey, United States, 07601|
|Principal Investigator:||Benno G Roesch, MD||Advanced Biomedical Research, Inc.|