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Safety and Pharmacokinetics Study of CARD-024 in Healthy Subjects

NCT01757860 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2012-12-31

No results posted yet for this study

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

Conditions

  • Drug Safety
  • Heart; Disease, Activity

Interventions

DRUG

CARD-024

Comparison of different dosages of drug

OTHER

Drug Carrier

Drug Carrier, 20% ethanol:80% propylene glycol oral administered solution.

Sponsors & Collaborators

  • Cardiavent Inc.

    lead INDUSTRY

Principal Investigators

  • James Vanderlugt, MD · Jasper Clinic, Michigan

  • Robert U Simpson, PhD · Cardiavent Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2011-12-31
Completion
2012-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01757860 on ClinicalTrials.gov