VA111913 TS: First in Human Study

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vantia Ltd

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