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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo | Placebo Comparator | Subjects received an oral single dose of placebo capsule matched to the SKI2670 dose (Placebo for SKI2670) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SKI2670 | Drug | Oral, Single Dose |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of SKI2670 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyun-Seop Bae, MD,PhD | Asan Medical Center Department of Clinical Pharmacology and Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 138-736 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41420759 | Derived | Bae SH, Kang J, Jeon S, Kim SM, Kim HT, Han S, Han S. Pharmacokinetic-Pharmacodynamic Modeling and Simulation of Merigolix, a Nonpeptide Gonadotropin-Releasing Hormone Antagonist. Clin Pharmacokinet. 2026 Mar;65(3):377-393. doi: 10.1007/s40262-025-01595-0. Epub 2025 Dec 20. | |
| 33347565 | Derived | 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. |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C000719429 | TU2670 |
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| Placebo | Drug | Same shape as the experimental drug |
|
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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) | 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 |
| D000091662 | Genital Diseases |