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Completed

NCT Number: NCT02202408

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female, 20 years of age and older
  • Weight between 40kg~70kg
  • Women who agreed using double contraception method and spermicide, avoiding breast-feeding for at least 30days after IP(investigational product) dosing
  • 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

  • Women who are pregnant or serum/urine hCG(human chorionic gonadotropin) positive or breast-feeding
  • A history of breast cancer, genital cancer or any estrogen dependent tumor
  • Specified or unspecified diagnosed infertility or history of natural abortion over three times
  • 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
  • Clinically significant Gynecological disease identified by ultrasonography including estrogen dependent tumor or lesion, sever inflammation or synechia
  • AST(Aspartate aminotransferase), ALT(Alanine aminotransferase) ≥ 2.5 times the upper limit of normal
  • QTc > 450ms on electrocardiogram result

Treatment and study plan

SKI2670

Drug

Oral, Single Dose

Other names: N/A(only SKI2670)

Placebo

Drug

Same shape as the experimental drug

Other names: N/A(only 1 Placebo)

Primary outcomes

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

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

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

Secondary outcomes

  1. 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

    Peak Plasma Concentration (Cmax) of SKI2670

  2. 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

    Area Under Curve (AUC) of SKI2670

  3. 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

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

Sponsors and collaborators

Lead sponsor

SK Chemicals Co., Ltd.

Industry

Registry information

Official study title

A Phase I, Double-blind, Randomized, Placebo-controlled, Single-Dose Escalation, First-in-human Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SKI2670

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 29, 2014
Registry last updated
Oct 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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