NCT01757860

Safety and Pharmacokinetics Study of CARD-024 in Healthy Subjects

A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of CARD-024 (1α-Hydroxy-Vitamin-D5) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Cardiavent Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed 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

Conditions

• Drug Safety
• Heart; Disease, Activity

Interventions

Type	Name	Description
DRUG	CARD-024	Comparison of different dosages of drug
OTHER	Drug Carrier	Drug Carrier, 20% ethanol:80% propylene glycol oral administered solution.

Timeline

• Start date: 2011-09-01
• Primary completion: 2011-12-01
• Completion: 2012-01-01
• First posted: 2012-12-31
• Last updated: 2012-12-31

Locations

1 site across 1 country: United States