Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SKI2670

• ClinicalTrials.gov Identifier: NCT02202408
• Recruitment Status: Completed
• First Posted: July 29, 2014
• Last Update Posted: October 20, 2017
• Sponsor: SK Chemicals Co., Ltd.
• Information provided by (Responsible Party): SK Chemicals Co., Ltd.

Tracking Information

• First Submitted Date: July 16, 2014
• First Posted Date: July 29, 2014
• Last Update Posted Date: October 20, 2017
• Study Start Date: June 2014
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 11, 2016)

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.

Original Primary Outcome Measures (submitted: July 24, 2014)

Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: From day 1 to day 14±7 after a single oral dose. ]

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

Current Secondary Outcome Measures (submitted: October 18, 2017)

• 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
• 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
• 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)

Original Secondary Outcome Measures (submitted: July 24, 2014)

• 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 LH [ Time Frame: day -1, 0h(pre-dose), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 30h, 36h, 48h, 72h, day 7±5, day 14±5 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SKI2670
• 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Endometriosis

Intervention

• Drug: SKI2670
  Oral, Single Dose
  Other Name: N/A(only SKI2670)
• Drug: Placebo
  Same shape as the experimental drug
  Other Name: N/A(only 1 Placebo)

Study Arms

• Experimental: SKI2670

  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

  Intervention: Drug: SKI2670
• Placebo Comparator: Placebo
  Subjects received an oral single dose of placebo capsule matched to the SKI2670 dose (Placebo for SKI2670)
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 24, 2014): 16
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 2016
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT02202408
• Other Study ID Numbers: SKI2670_EMSD_I_2013
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: SK Chemicals Co., Ltd.
• Study Sponsor: SK Chemicals Co., Ltd.
• Collaborators: Not Provided

Investigators

• Study Chair: Kyun-Seop Bae, MD,PhD; Asan Medical Center Department of Clinical Pharmacology and Therapeutics

• PRS Account: SK Chemicals Co., Ltd.
• Verification Date: August 2016