Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00461370
Status:
COMPLETED
Last Update Posted:
2008-03-13
First Post:
2007-04-16
Brief Title:
Safety Study of SRX251 Capsules in Healthy Female Volunteers
Sponsor:
Azevan Pharmaceuticals
Organization:
Azevan Pharmaceuticals
Study Overview
Official Title:
Phase I Double-Blind Placebo-Controlled Ascending Single-Dose Safety Tolerability and Pharmacokinetic Study of SRX251 Capsules in Healthy Female Volunteers
Status:
COMPLETED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AVN001
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None