Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-03-08 @ 11:25 PM
Study NCT ID:
NCT01757860
Status:
COMPLETED
Last Update Posted:
2012-12-31
First Post:
2012-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetics Study of CARD-024 in Healthy Subjects
Sponsor:
Cardiavent Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARD-024
Brief 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
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
The planned cohorts are:
Cohort CARD-024 Dose\*
1. 3 μg
2. 9 μg
3. 27 μg
4. 81 μg
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: