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Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SKI2670

NCT ID: NCT02202408

Last Updated: 2017-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-08-31

Brief Summary

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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

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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.

Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

SKI2670

Intervention Type DRUG

Oral, Single Dose

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Same shape as the experimental drug

Interventions

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SKI2670

Oral, Single Dose

Intervention Type DRUG

Placebo

Same shape as the experimental drug

Intervention Type DRUG

Other Intervention Names

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N/A(only SKI2670) N/A(only 1 Placebo)

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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SK Chemicals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyun-Seop Bae, MD,PhD

Role: STUDY_CHAIR

Asan Medical Center Department of Clinical Pharmacology and Therapeutics

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 33347565 (View on PubMed)

Other Identifiers

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SKI2670_EMSD_I_2013

Identifier Type: -

Identifier Source: org_study_id