drugset / Trial / NCT06034015
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of APL-1501 Extended Release (ER) Capsules Compared to APL-1202 Immediate Release (IR) Tablets in Healthy Volunteers
Non-randomizedSequentialOpen-labelTreatment
Summary
This is an integrated Phase 1, single centre, 2-part, open-label, dose-escalation study conducted in healthy volunteers to assess the safety, tolerability, and PK of APL-1501 ER capsules in comparison to APL-1202 IR tablets.
Timeline
- Start
- 2023-09-09
- Primary completion
- 2024-01-19
- Completion
- 2024-02-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | APL-1202 | Unknown | 375 mg | Oral |
| Comparator | APL-1501 | Unknown | 764 mg | — |
| Comparator | APL-1501 | Unknown | 1146 mg | — |
| Comparator | APL-1501 | Unknown | 1528 mg | — |