Clinical trial NCT02202408: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Endometriosis
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-07-29
Enrollment: 16
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: From day 1 to day 16~26D after a single oral dose.
Secondary outcomes:
measure: Peak Plasma Concentration (Cmax) of SKI2670
timeFrame: 0h(pre-dose), 10min, 20min, 30min, 45min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h
measure: Area Under Curve (AUC) of SKI2670
timeFrame: 0h(pre-dose), 10min, 20min, 30min, 45min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h
measure: Concentration Change from Baseline(%) of Luteinizing Hormone (LH)
timeFrame: day -1, 0h(pre-dose), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 30h, 36h, 48h, 72h, day 7~12D, 16~26D
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center Department of Clinical Pharmacology and Therapeutics
name: Kyun-Seop Bae, MD,PhD
role: STUDY_CHAIR
References:
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.