Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SKI2670

Phase 1CompletedNCT02202408

SK Chemicals Co., Ltd.16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Endometriosis

Interventions

SKI2670DRUG

Oral, Single Dose

PlaceboDRUG

Same shape as the experimental drug

Eligibility

Sex: FEMALEMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Asan Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

All participants who ever were administered with investigational product are assessed.

Time frame: From day 1 to day 16~26D after a single oral dose.

Secondary Outcomes

Peak Plasma Concentration (Cmax) of SKI2670

Time frame: 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

Time frame: 0h(pre-dose), 10min, 20min, 30min, 45min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h

Concentration Change from Baseline(%) of Luteinizing Hormone (LH)

Time frame: day -1, 0h(pre-dose), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 30h, 36h, 48h, 72h, day 7~12D, 16~26D

Data from ClinicalTrials.gov

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