Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06698549 | A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Renal Impairment and in Healthy Subjects With Normal Renal Function | PHASE1 | COMPLETED | 12 | — | — | Feb 20, 2025 | Aug 13, 2025 | May 26, 2026 | 3 | United States |
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in urine
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in urine
| Arm | Type | Description |
|---|---|---|
| Subjects with Severe Renal Impairment | EXPERIMENTAL | Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses. |
| Subjects with Normal Renal Function | EXPERIMENTAL | Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses. |
| Subjects with Mild Renal Impairment (Optional) | EXPERIMENTAL | Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses. |
| Subjects with Moderate Renal Impairment (Optional) | EXPERIMENTAL | Subjects with moderate renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses. |
| Name | Type | Description |
|---|---|---|
| ALG-097558 | DRUG | Multiple doses of ALG-097558 300 mg (3 x 100 mg tablets) |
Inclusion Criteria for All Subjects: 1. Male and Female between 18 and 75 years old 2. Body Mass Index (BMI) 17.5 to 40.0 kg/m\^2 and a total body weight \>50 kg (110 lb) 3. Female subjects must either be not of childbearing potential or if they are a woman of childbearing potential, they are only ...