Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SKI2670

SK chemicals

Status and phase: Completed; Phase 1

Conditions: Endometriosis

Treatments: Drug: Placebo; Drug: SKI2670

Study type: Interventional

Funder types: Industry

Identifiers

NCT02202408

SKI2670_EMSD_I_2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: Female

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups, including a placebo group

SKI2670

Experimental group

Description:

Single-dose escalation/ Subjects received an oral single dose of SKI2670 capsule by dosing group -Dosing Group 1, Dosing Group 2, Dosing Group 3, Dosing Group 4

Treatment:

Drug: SKI2670

Placebo

Placebo Comparator group

Description:

Subjects received an oral single dose of placebo capsule matched to the SKI2670 dose (Placebo for SKI2670)

Treatment:

Drug: Placebo