Trials / Active Not Recruiting
Active Not RecruitingNCT06729853
PK and Safety Evaluation Study of SAP-001 in Adult Subjects With Normal and Impaired Renal Function
A Phase 1, Open-Label, Parallel-Group, Single-Dose Adaptive Study to Evaluate the Safety and Pharmacokinetics of SAP-001 in Adult Subjects With Normal and Impaired Renal Function
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- Sponsor
- Shanton Pharma Pte. Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
This is a multicenter, open-label, non-randomized, parallel-group, single-dose, 2-part, adaptive study in which up to approximately 32 adult subjects will be enrolled in one of 4 groups (8 subjects per group) with varying degrees of renal function.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SAP-001 | a single oral dose of SAP-001 |
Timeline
- Start date
- 2024-04-24
- Primary completion
- 2025-01-17
- Completion
- 2025-04-28
- First posted
- 2024-12-11
- Last updated
- 2024-12-11
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06729853. Inclusion in this directory is not an endorsement.