Endometriosis
Conditions
Brief 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.
Detailed description
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.
Interventions
DRUGSKI2670
Oral, Single Dose
DRUGPlacebo
Same shape as the experimental drug
Sponsors
SK Chemicals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | From day 1 to day 16~26D after a single oral dose. | All participants who ever were administered with investigational product are assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) of SKI2670 | 0h(pre-dose), 10min, 20min, 30min, 45min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h | Peak Plasma Concentration (Cmax) of SKI2670 |
| Area Under Curve (AUC) of SKI2670 | 0h(pre-dose), 10min, 20min, 30min, 45min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h | Area Under Curve (AUC) of SKI2670 |
| Concentration Change from Baseline(%) of Luteinizing Hormone (LH) | day -1, 0h(pre-dose), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 30h, 36h, 48h, 72h, day 7~12D, 16~26D | Concentration Change from Baseline(%) of Luteinizing Hormone (LH) |
Countries
South Korea
Outcome results
None listed