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

October 8, 2008
June 24, 2009
September 2008
March 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00769964 on ClinicalTrials.gov Archive Site
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VA111913 TS: First in Human Study
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

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Primary Purpose: Treatment
Dysmenorrhea
Drug: VA111913 TS / placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
March 2009
March 2009   (final data collection date for primary outcome measure)

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

Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00769964
913-001
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Acting Medical Director, Charles River Clinical Services
Vantia Ltd
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Vantia Ltd
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP