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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
34
Comparison of different dosages of drug
Drug Carrier, 20% ethanol:80% propylene glycol oral administered solution.
Jasper Clinic
Kalamazoo, Michigan, United States
Safety
Adverse events such as nausea, vomiting, headache, muscle ache, neuralgia and patient overall tolerance to drug.
Time frame: 5 days
Drug Pharmacokinetics
Measure of drug absorption and elimination by measuring drug blood levels after oral administration. Assessment of drug C-max, T-lag, T-1/2, AUC, Vd/F and K-a.
Time frame: 5 days
Drug Pharmacodynamics
Measure of pharmacodynamics by 1\] measuring plasma renin activity (PRA), 2\] measuring plasma parathyroid hormone (PTH) levels, and 3\] measuring drug effect on systolic and diastolic blood pressure by arm cuff occlusion.
Time frame: 5 days
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