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Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SKI2670

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

Tracking Information
First Submitted Date  ICMJE July 16, 2014
First Posted Date  ICMJE July 29, 2014
Last Update Posted Date October 20, 2017
Study Start Date  ICMJE June 2014
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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.
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SKI2670
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Endometriosis
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 24, 2014)
16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02202408
Other Study ID Numbers  ICMJE SKI2670_EMSD_I_2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party SK Chemicals Co., Ltd.
Study Sponsor  ICMJE SK Chemicals Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP