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drugset / Trial / NCT04316143

Pharmacokinetics, Safety and Efficacy of BIA 5-1058 in PAH (Zamicastat)

NCT04316143 ↗

Phase 2 Completed 33 enrolled Bial - Portela C S.A.
Non-randomizedSequentialOpen-labelTreatment

Summary

This Study evaluates the pharmacokinetic (PK) profile of different zamicastat doses in Pulmonary arterial hypertension (PAH) patients to find the most promising therapeutic dosage range for the treatment of PAH disease

Timeline

Start
2019-06-03
Primary completion
2021-10-20
Completion
2021-10-20

Drugs

EvaluationDrugModalityDoseRoute
Subject zamicastat Small molecule 50 mg Oral
Subject zamicastat Small molecule 100 mg Oral
Subject zamicastat Small molecule 150 mg Oral
Subject zamicastat Small molecule 200 mg Oral

Indications

pulmonary arterial hypertension