drugset / Trial / NCT01757860

Safety and Pharmacokinetics Study of CARD-024 in Healthy Subjects

NCT01757860 ↗

Phase 1 Completed 34 enrolled Cardiavent Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Study Phase: Phase 1 Primary Objective: • To evaluate the safety and tolerability of single ascending oral doses of CARD-024 in healthy subjects Secondary Objectives: * To evaluate the pharmacokinetic (PK) profile of CARD-024 following ascending single oral doses of CARD-024 * To evaluate the effect of CARD-024 on cardiovascular indices including plasma renin activity (PRA) and blood pressure (BP), biological markers of activity, following ascending single oral doses of CARD-024

Timeline

Start
2011-09
Primary completion
2011-12
Completion
2012-01

Drugs

EvaluationDrugModalityDoseRoute
Subject 1.ALPHA.-HYDROXYVITAMIN D5 Small molecule 3 ug Oral
Subject 1.ALPHA.-HYDROXYVITAMIN D5 Small molecule 9 ug Oral
Subject 1.ALPHA.-HYDROXYVITAMIN D5 Small molecule 27 ug Oral
Subject 1.ALPHA.-HYDROXYVITAMIN D5 Small molecule 81 ug Oral

Indications