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Safety and Pharmacokinetics Study of CARD-024 in Healthy Subjects (CARD-024)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01757860
Recruitment Status : Completed
First Posted : December 31, 2012
Last Update Posted : December 31, 2012
Information provided by (Responsible Party):
Cardiavent Inc.

Tracking Information
First Submitted Date  ICMJE December 17, 2012
First Posted Date  ICMJE December 31, 2012
Last Update Posted Date December 31, 2012
Study Start Date  ICMJE September 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 28, 2012)
Safety [ Time Frame: 5 days ]
Adverse events such as nausea, vomiting, headache, muscle ache, neuralgia and patient overall tolerance to drug.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 28, 2012)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 28, 2012)
Induction of Hypercalcemia [ Time Frame: 5 days ]
Measure of serum calcium levels post treatment to assess drug calcemic activity.
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE Safety and Pharmacokinetics Study of CARD-024 in Healthy Subjects
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Drug Safety
  • Heart; Disease, Activity
Intervention  ICMJE
  • Drug: CARD-024
    Comparison of different dosages of drug
    Other Name: 1α-Hydroxy-Vitamin-D5; 1αVitD5
  • Other: Drug Carrier
    Drug Carrier, 20% ethanol:80% propylene glycol oral administered solution.
    Other Name: Placebo, Drug Carrier
Study Arms  ICMJE
  • Experimental: CARD-024
    CARD-024 oral administered: 3, 9, 27 or 81 mcg.
    Intervention: Drug: CARD-024
  • Placebo Comparator: Drug Carrier
    Placebo: 20% ethanol:80% propylene glycol solution oral administered.
    Intervention: Other: Drug Carrier
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 28, 2012)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy males and females between the ages of 18 and 55, inclusive, with body mass index (BMI) between 18-32 kg/m2.
  2. Females must be surgically sterile or at least 2 years post-menopausal. Menopausal status will be verified by a follicular stimulating hormone (FSH) test. Those with bilateral tubal ligation must also use a barrier method of birth control. In addition, all females must have a negative pregnancy test at Screening.
  3. No clinically significant findings on physical examination, including BP, pulse rate and 12-lead ECG. No clinically significant medical history.
  4. No clinically significant safety laboratory results at Screening. Cardiavent, Inc. - CONFIDENTIAL
  5. Nonsmoker or light smoker (≤5 cigarettes per day or similar use of other tobacco products) and are willing to refrain from smoking while in the clinic.
  6. Willing and able to sign an informed consent document indicating understanding the purpose of and procedures required for the study and willingness to participate in the study.
  7. Willing and able to stay in the clinic for the inpatient activities required by the protocol for all visits.

Exclusion Criteria:

  1. Evidence of clinically relevant pathology that could interfere with the study results or put the subject's safety at risk.
  2. Current or recurrent disease that may affect the action, absorption, or disposition of the study treatment, or clinical or laboratory assessments.
  3. Current or relevant previous history of serious, severe, or unstable (acute or progressive) physical or psychiatric illness, any medical disorder requiring treatment or that may make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study treatment or procedures.
  4. History of febrile illness within the 5 days prior to the first dose.
  5. Positive Hepatitis B surface antigen (HbsAg), Hepatitis C antibody or Human Immunodeficiency Virus (HIV) test result at Screening visit.
  6. Use of any prescription medication or over-the-counter (OTC) medication within 7 days or 5 half-lives (whichever is longer) prior to the first dose of trial medication or during the study. As an exception, acetaminophen may be used at doses up to 1 g/day.
  7. Use of any herbal supplements (including herbal weight-loss or "metabolism booster" therapies) within 30 days prior to the first dose of trial medication.
  8. Known or suspected intolerance or hypersensitivity to similar study drugs or excipients, closely related compounds or any of their stated ingredients.
  9. Positive screen for alcohol or drugs of abuse during Screening visit or at study check-in for Day 1 dosing.
  10. Participated in a clinical study involving an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to study drug administration.
  11. Blood donation of 1 pint or more within 56 days of the start of the study.
  12. Plasmapheresis or plasma donation within 30 days of the start of the study.
  13. Single 12-lead ECG demonstrating QTc >450 msec at Screening, and or history or evidence of long QT syndrome. A single repeat ECG may be done at the Principal Investigator's discretion.
  14. Any condition that in the opinion of the Principal Investigator would complicate or compromise the study or the well-being of the subject.
  15. Unwilling or unable to comply with the clinic house rules.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01757860
Other Study ID Numbers  ICMJE CARD-024-C001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cardiavent Inc.
Study Sponsor  ICMJE Cardiavent Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Vanderlugt, MD Jasper Clinic, Michigan
Study Chair: Robert U Simpson, PhD Cardiavent Inc.
PRS Account Cardiavent Inc.
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP