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Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SKI2670

Primary Purpose

Endometriosis

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

SKI2670

Placebo

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SKI2670

Placebo

Arm Description

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

Subjects received an oral single dose of placebo capsule matched to the SKI2670 dose (Placebo for SKI2670)

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Peak Plasma Concentration (Cmax) of SKI2670

Area Under Curve (AUC) of SKI2670

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

Full Information

NCT ID

NCT02202408

First Posted

July 16, 2014

Last Updated

October 18, 2017

Sponsor

SK Chemicals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02202408

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

June 2014 (undefined)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SK Chemicals Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometriosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SKI2670

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Subjects received an oral single dose of placebo capsule matched to the SKI2670 dose (Placebo for SKI2670)

Intervention Type

Drug

Intervention Name(s)

SKI2670

Other Intervention Name(s)

N/A(only SKI2670)

Intervention Description

Oral, Single Dose

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

N/A(only 1 Placebo)

Intervention Description

Same shape as the experimental drug

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Peak Plasma Concentration (Cmax) of SKI2670

Description

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

Title

Area Under Curve (AUC) of SKI2670

Description

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

Title

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

Description

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kyun-Seop Bae, MD,PhD

Organizational Affiliation

Asan Medical Center Department of Clinical Pharmacology and Therapeutics

Official's Role

Study Chair

Facility Information:

Facility Name

Asan Medical Center

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

33347565

Citation

Han S, Cho YS, Yoon SK, Lim KS, Cho SH, Kim J, Choe S, Jung J, Ghim JL, Choi S, Lee M, Kim SM, Kim HT, Lim HS, Yoon Shim J, Bae KS. First-in-Human, Double-Blind, Randomized Controlled Trial of an Oral Dose of GnRH Antagonist TU2670 in Healthy Women. J Clin Endocrinol Metab. 2021 Mar 8;106(3):e1111-e1120. doi: 10.1210/clinem/dgaa939.

Results Reference

derived

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Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SKI2670

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