Phase 1 Study of PK and Safety of HM15912 (Sonefpeglutide) in Subjects With Normal and Severe Kidney Function
Фаза 1
Завершено
NCT05711381
| Заболевание | Renal Impairment |
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| Фаза | Фаза 1 |
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| Спонсор | Hanmi Pharmaceutical Company Limited |
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| Статус | Завершено |
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| Участники | 16 участн. |
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| Вмешательство | HM15912 |
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| Дата начала | 2.12.2022 |
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| Дата завершения | 15.08.2023 |
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| Публикация результатов | 4.04.2025 |
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Кратко
An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HM15912 in Subjects with Renal Impairment and Matched Control Subjects with Normal Renal Function
Maximum Serum Concentration (Cmax) of HM15912
Day 1 to 29 (Total duration: 29 days) · ng/mL
| Severe Renal Impairment | 2811.25 ± 1498.985 ng/mL |
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| Normal Renal Function | 3000.00 ± 1174.114 ng/mL |
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| Geometric mean ratio | 0.91 (95% CI 0.59–1.41) |
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Area Under the Concentration-time Curve From Extrapolated to Infinity (AUC 0-infinity) of HM15912
Day 1 to 29 (Total duration: 29 days) · h*ng/mL
| Severe Renal Impairment | 1117469.3 ± 347572.67 h*ng/mL |
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| Normal Renal Function | 890343.8 ± 235565.36 h*ng/mL |
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| Geometric mean ratio | 1.25 (95% CI 0.93–1.68) |
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