Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SKI2670

Endometriosis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02202408
• Other study ID #: SKI2670_EMSD_I_2013
• Status: Completed
• Phase: Phase 1
• First received: July 16, 2014
• Last updated: October 18, 2017
• Start date: June 2014
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: SK Chemicals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• SKI2670
Oral, Single Dose
• Placebo
Same shape as the experimental drug

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SK Chemicals Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	All participants who ever were administered with investigational product are assessed.	From day 1 to day 16~26D after a single oral dose.
Secondary	Peak Plasma Concentration (Cmax) of SKI2670	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
Secondary	Area Under Curve (AUC) 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
Secondary	Concentration Change from Baseline(%) of Luteinizing Hormone (LH)	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