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Clinical Trial 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


Clinical Trial Description

Study Design: This is a single-center, double-blind, randomized, placebo-controlled study of single oral doses of CARD-024. Four planned cohorts of 8 subjects each will be dosed sequentially and randomized to receive a single dose of active drug (6 subjects) or placebo (2 subjects). Cohort 4 will have 10 subjects randomized to receive active drug (7 subjects) or placebo (3 subjects). Each cohort will be divided into at least 2 groups; the first group will have 2 subjects, 1 receiving active drug and 1 receiving placebo. Dosing of the remaining 6 subjects in each cohort will be completed in a manner agreed upon by the Sponsor and the Principal Investigator in keeping with the randomization schedule and blinded conditions.

The planned cohorts are:

Cohort CARD-024 Dose*

1. 3 μg

2. 9 μg

3. 27 μg

4. 81 μg ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01757860
Study type Interventional
Source Cardiavent Inc.
Contact
Status Completed
Phase Phase 1
Start date September 2011
Completion date January 2012

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