Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SKI2670

NCT02202408 | Completed Phase 1

• 1 other identifier: SKI2670_EMSD_I_2013
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

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

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

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

Secondary Outcomes (3)

• Peak Plasma Concentration (Cmax) of SKI2670

  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

  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 Luteinizing Hormone (LH)

  day -1, 0h(pre-dose), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 30h, 36h, 48h, 72h, day 7~12D, 16~26D

Study Arms (2)

SKI2670

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

SKI2670 DRUG

Oral, Single Dose

Also known as: N/A(only SKI2670)

SKI2670

Placebo DRUG

Same shape as the experimental drug

Also known as: N/A(only 1 Placebo)

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SK Chemicals Co., Ltd.: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (1)

• 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.

  PMID: 33347565 DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

TU2670

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Kyun-Seop Bae, MD,PhD

  Asan Medical Center Department of Clinical Pharmacology and Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 29, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 20, 2017

Record last verified: 2016-08

Locations

KR (1)