VA111913 TS: First in Human Study - Full Text View

Sponsored by:	Vantia Ltd
Information provided by:	Vantia Ltd
ClinicalTrials.gov Identifier:	NCT00769964

Purpose

This is a first-in-human study of VA111913 TS, a new chemical entity being developed for the treatment of dysmenorrhea. This study is designed to investigate determine the safety, tolerability and pharmacokinetics of VA111913 TS after single and multiple doses in healthy non-pregnant female volunteers of child bearing age.

Condition	Intervention	Phase
Dysmenorrhea	Drug: VA111913 TS / placebo	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Safety Study
Official Title:	A First in Human Study Consisting of a Two-Part, Double-Blind, Placebo-Controlled, Escalating Single and Multiple Dose Study of VA111913 TS in Adult Non-Pregnant Women Volunteers With a Single Dose, Open, Fed vs. Fasting Crossover Phase

Further study details as provided by Vantia Ltd:

Estimated Enrollment:	121
Study Start Date:	September 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Detailed Description:

VA111913 TS is a selective V1a-receptor antagonist. The hypothesised mechanism of action of a V1a receptor antagonist in dysmenorrhea has been described in literature. Contractions of the uterine muscle are required for normal menstruation. Women with dysmenorrhea have increased uterine myometrial tone and contractions and decreased blood flow to the uterus. These abnormalities have been shown to lead to the pain experienced in dysmenorrhea. Thus, if a drug is able to reduce the hyperreactivity of the uterus to physiological levels then the pain experienced in dysmenorrhea may be controlled. In humans, vasopressin, via the V1a receptor, is able to potently induce contractions in both uterine smooth muscle and uterine blood vessels. Thus, a V1a receptor antagonist will potentially inhibit these contractions and in turn reduce the pain experienced in dysmenorrhea.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy females 18 to 45 years of age.
Subjects must have a negative pregnancy test at screening and admission. Using acceptable form of contraceptive during and after study.

Exclusion Criteria:

Administration of any IMP within 12 weeks before entry to the study or any prescribed medicine within 14days of the study.
Any clinically important medical disease, condition or abnormal laboratory test results.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769964

Contacts

Contact: Volunteer Recruitment Manager

+44 1800 277477

Locations

United Kingdom
Charles River Clinical Services	Recruiting
Edinburgh, United Kingdom, EH33 2NE
Principal Investigator: Acting Medical Director

Sponsors and Collaborators

Vantia Ltd

More Information

No publications provided

Responsible Party:	Charles River Clinical Services ( Acting Medical Director )
Study ID Numbers:	913-001
Study First Received:	October 8, 2008
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00769964 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Vantia Ltd:

Healthy (Dysmenorrhea)

Study placed in the following topic categories:

Signs and Symptoms
Pelvic Pain
Menstruation Disturbances

Dysmenorrhea
Pain
Healthy

Additional relevant MeSH terms:

Signs and Symptoms
Pelvic Pain
Pathologic Processes

Menstruation Disturbances
Dysmenorrhea
Pain

ClinicalTrials.gov processed this record on May 07, 2009