Safety and Pharmacokinetics Study of CARD-024 in Healthy Subjects
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
Heart; Disease, Activity
Other: Drug Carrier
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Safety [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]Adverse events such as nausea, vomiting, headache, muscle ache, neuralgia and patient overall tolerance to drug.
- Drug Pharmacokinetics [ Time Frame: 5 days ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]Measure of serum calcium levels post treatment to assess drug calcemic activity.
|Study Start Date:||September 2011|
|Study Completion Date:||January 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
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
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
Please refer to this study by its ClinicalTrials.gov identifier: 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.|