drugset / Trial / NCT03836222
Study to Evaluate the PK of Single and Optional Multiple Dosing Regimens of MR Formulations of PCS499 Compared to Trental® Administered to Healthy Subjects
Non-randomizedSequentialOpen-labelBasic science
Summary
This was a Phase I, single centre, open-label, non-randomised study and was designed to be conducted in up to 2 parts. The purpose of Part 1 was to identify a MR formulation of PCS499 that would provide an optimal dosing regimen in patients. The purpose of Part 2 of the study was to generate repeat dose information for the selected MR formulation of PCS499 in order to provide additional PK information for future patient studies.
Timeline
- Start
- 2018-02-26
- Primary completion
- 2018-06-04
- Completion
- 2018-06-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CTP-499 | Small molecule | 600 mg | — |
| Subject | CTP-499 | Small molecule | 900 mg | — |
| Comparator | Pentoxifylline | Small molecule | 400 mg | — |
Indications
No indication recorded.