VA111913 TS: First in Human Study

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: NCT00769964
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : June 25, 2009
Information provided by:
Vantia Ltd

Brief Summary:
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 or disease Intervention/treatment Phase
Dysmenorrhea Drug: VA111913 TS / placebo Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Primary Purpose: Treatment
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
Study Start Date : September 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

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): NCT00769964

United Kingdom
Charles River Clinical Services
Edinburgh, United Kingdom, EH33 2NE
Sponsors and Collaborators
Vantia Ltd

Responsible Party: Acting Medical Director, Charles River Clinical Services Identifier: NCT00769964     History of Changes
Other Study ID Numbers: 913-001
First Posted: October 9, 2008    Key Record Dates
Last Update Posted: June 25, 2009
Last Verified: June 2009

Keywords provided by Vantia Ltd:
Healthy (Dysmenorrhea)

Additional relevant MeSH terms:
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Neurologic Manifestations
Signs and Symptoms