Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SKI2670
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SKI2670
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.
In this Phase I study, the primary objective is to investigate the safety and tolerability of
 SKI2670 after oral administration in healthy female subjects.

 Secondary objective is to investigate the pharmacokinetics and pharmacodynamics of SKI2670
 after oral administration in healthy female subjects.
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