VA111913 TS: First in Human Study

This study has been completed.
Sponsor:
Information provided by:
Vantia Ltd
ClinicalTrials.gov Identifier:
NCT00769964
First received: October 8, 2008
Last updated: June 24, 2009
Last verified: June 2009
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
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

Further study details as provided by Vantia Ltd:

Enrollment: 98
Study Start Date: September 2008
Study Completion Date: March 2009
Primary Completion Date: March 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Acting Medical Director, Charles River Clinical Services
ClinicalTrials.gov Identifier: NCT00769964     History of Changes
Other Study ID Numbers: 913-001
Study First Received: October 8, 2008
Last Updated: June 24, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Vantia Ltd:
Healthy (Dysmenorrhea)

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

ClinicalTrials.gov processed this record on August 01, 2014