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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.

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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: SKI2670 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : June 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Arm Intervention/treatment
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

Drug: SKI2670
Oral, Single Dose
Other Name: N/A(only SKI2670)

Placebo Comparator: Placebo
Subjects received an oral single dose of placebo capsule matched to the SKI2670 dose (Placebo for SKI2670)
Drug: Placebo
Same shape as the experimental drug
Other Name: N/A(only 1 Placebo)




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202408


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
SK Chemicals Co., Ltd.
Investigators
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Study Chair: Kyun-Seop Bae, MD,PhD Asan Medical Center Department of Clinical Pharmacology and Therapeutics
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Responsible Party: SK Chemicals Co., Ltd.
ClinicalTrials.gov Identifier: NCT02202408    
Other Study ID Numbers: SKI2670_EMSD_I_2013
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Endometriosis