Safety and Pharmacokinetics Study of CARD-024 in Healthy Subjects (CARD-024)
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|ClinicalTrials.gov Identifier: NCT01757860|
Recruitment Status : Completed
First Posted : December 31, 2012
Last Update Posted : December 31, 2012
Study Phase: Phase 1
• To evaluate the safety and tolerability of single ascending oral doses of CARD-024 in healthy subjects
- 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
|Condition or disease||Intervention/treatment||Phase|
|Drug Safety Heart; Disease, Activity||Drug: CARD-024 Other: Drug Carrier||Phase 1|
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*
- 3 μg
- 9 μg
- 27 μg
- 81 μg
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||January 2012|
CARD-024 oral administered: 3, 9, 27 or 81 mcg.
Comparison of different dosages of drug
Other Name: 1α-Hydroxy-Vitamin-D5; 1αVitD5
Placebo Comparator: Drug Carrier
Placebo: 20% ethanol:80% propylene glycol solution oral administered.
Other: Drug Carrier
Drug Carrier, 20% ethanol:80% propylene glycol oral administered solution.
Other Name: Placebo, Drug Carrier
- Safety [ Time Frame: 5 days ]Adverse events such as nausea, vomiting, headache, muscle ache, neuralgia and patient overall tolerance to drug.
- Drug Pharmacokinetics [ Time Frame: 5 days ]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.
- Drug Pharmacodynamics [ Time Frame: 5 days ]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.
- Induction of Hypercalcemia [ Time Frame: 5 days ]Measure of serum calcium levels post treatment to assess drug calcemic activity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757860
|United States, Michigan|
|Kalamazoo, Michigan, United States, 49007|
|Principal Investigator:||James Vanderlugt, MD||Jasper Clinic, Michigan|
|Study Chair:||Robert U Simpson, PhD||Cardiavent Inc.|