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
1 other identifier
interventional
98
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2008
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 8, 2008
CompletedFirst Posted
Study publicly available on registry
October 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedJune 25, 2009
June 1, 2009
6 months
October 8, 2008
June 24, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vantia Ltdlead
Study Sites (1)
Charles River Clinical Services
Edinburgh, EH33 2NE, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 8, 2008
First Posted
October 9, 2008
Study Start
September 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
June 25, 2009
Record last verified: 2009-06