Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT01757860
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
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
Study:
NCT01757860
Study Brief:
Protocol Section:
NCT01757860