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

NCT03836222

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

EvaluationDrugModalityDoseRoute
Subject CTP-499 Small molecule 600 mg
Subject CTP-499 Small molecule 900 mg
Comparator Pentoxifylline Small molecule 400 mg

Indications

No indication recorded.