Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SKI2670

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

In this Phase I study, the primary objective is to investigate the safety and tolerability of SKI2670 after oral administration in healthy female subjects. And secondary objective is to investigate the pharmacokinetics and pharmacodynamics of SKI2670 after oral administration in healthy female subjects.

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

Details

• Lead Sponsor: SK Chemicals Co., Ltd.; SK Chemicals Co.,Ltd.

Criteria

Inclusion Criteria:

1. Female, 20 years of age and older

2. Weight between 40kg~70kg

3. Women who agreed using double contraception method and spermicide, avoiding breast-feeding for at least 30days after IP(investigational product) dosing

4. A history of regular menstrual cycles (cycle: 28±7day, duration: 2~7day) for at least 2 years and a positive ovulation test between day 11 and 21 in the preceding menstrual cycle of IP(investigational product) dosing

Exclusion Criteria:

1. Women who are pregnant or serum/urine hCG(human chorionic gonadotropin) positive or breast-feeding

2. A history of breast cancer, genital cancer or any estrogen dependent tumor

3. Specified or unspecified diagnosed infertility or history of natural abortion over three times

4. A history of taking other Investigational product within 60days before screening visit or taking ETC drug(Ethical drugs), oriental medicine or OTC drugs(Over-the-Counter drugs) within 14days before screening visit

5. Clinically significant Gynecological disease identified by ultrasonography including estrogen dependent tumor or lesion, sever inflammation or synechia

6. AST(Aspartate aminotransferase), ALT(Alanine aminotransferase) ≥ 2.5 times the upper limit of normal

7. QTc > 450ms on electrocardiogram result