Drug SafetyPhase 1CARD-024NCT01757860
Safety and Pharmacokinetics Study of CARD-024 in Healthy Subjects
A Phase 1 study testing CARD-024 and Drug Carrier in people with Drug Safety and Heart; Disease, Activity, run by Cardiavent Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Safety, Heart; Disease, Activity
- What is being tested?
- CARD-024 and Drug Carrier
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jan 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females between the ages of 18 and 55, inclusive, with body mass index (BMI) between 18-32 kg/m2.
- 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.
- No clinically significant findings on physical examination, including BP, pulse rate and 12-lead ECG. No clinically significant medical history.
- No clinically significant safety laboratory results at Screening. Cardiavent, Inc. - CONFIDENTIAL
- 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.
- 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.
- Willing and able to stay in the clinic for the inpatient activities required by the protocol for all visits.
Who cannot join
- Evidence of clinically relevant pathology that could interfere with the study results or put the subject's safety at risk.
- Current or recurrent disease that may affect the action, absorption, or disposition of the study treatment, or clinical or laboratory assessments.
- 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.
- History of febrile illness within the 5 days prior to the first dose.
- Positive Hepatitis B surface antigen (HbsAg), Hepatitis C antibody or Human Immunodeficiency Virus (HIV) test result at Screening visit.
- 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.
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- Use of any herbal supplements (including herbal weight-loss or "metabolism booster" therapies) within 30 days prior to the first dose of trial medication.
- Known or suspected intolerance or hypersensitivity to similar study drugs or excipients, closely related compounds or any of their stated ingredients.
- Positive screen for alcohol or drugs of abuse during Screening visit or at study check-in for Day 1 dosing.
- Participated in a clinical study involving an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to study drug administration.
- Blood donation of 1 pint or more within 56 days of the start of the study.
- Plasmapheresis or plasma donation within 30 days of the start of the study.
- 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.
- Any condition that in the opinion of the Principal Investigator would complicate or compromise the study or the well-being of the subject.
- Unwilling or unable to comply with the clinic house rules.
Trial locations and contacts
1 site in 1 country.
About this study
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 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
Read the 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*
- 3 μg
- 9 μg
- 27 μg
- 81 μg
- Conditions
- Drug Safety, Heart; Disease, Activity
- Being tested
- CARD-024, Drug Carrier
- Medical subject headings
- Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARD-024Drug
Also called 1α-Hydroxy-Vitamin-D5; 1αVitD5
Comparison of different dosages of drug
Drug CarrierOther
Also called Placebo, Drug Carrier
Drug Carrier, 20% ethanol:80% propylene glycol oral administered solution.
| Study group | Role | What they receive |
|---|---|---|
| CARD-024 | Experimental | CARD-024 oral administered: 3, 9, 27 or 81 mcg. Receives: Drug: CARD-024 |
| Drug Carrier | Placebo comparator | Placebo: 20% ethanol:80% propylene glycol solution oral administered. Receives: Other: Drug Carrier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Adverse events such as nausea, vomiting, headache, muscle ache, neuralgia and patient overall tolerance to drug.
Measured: 5 days
Secondary outcomes (2)
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.
Measured: 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.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2012 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiavent Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Vanderlugt, MD, Principal investigator, Jasper Clinic, MichiganRobert U Simpson, PhD, Study chair, Cardiavent Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757860
- Sponsor's protocol ID
- CARD-024-C001
- Acronym
- CARD-024
- Status last verified
- Dec 2012
- First submitted
- 17 Dec 2012
- Last updated
- 31 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01757860
- Acronym / sponsor ID
- CARD-024 / CARD-024-C001
- Conditions
- Drug Safety, Heart; Disease, Activity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Cardiavent Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 31 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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*
- 3 μg
- 9 μg
- 27 μg
- 81 μg
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CARD-024 | Experimental | Drug: CARD-024CARD-024 oral administered: 3, 9, 27 or 81 mcg. |
| Drug Carrier | Placebo comparator | Other: Drug CarrierPlacebo: 20% ethanol:80% propylene glycol solution oral administered. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy males and females between the ages of 18 and 55, inclusive, with body mass index (BMI) between 18-32 kg/m2.
- 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.
- No clinically significant findings on physical examination, including BP, pulse rate and 12-lead ECG. No clinically significant medical history.
- No clinically significant safety laboratory results at Screening. Cardiavent, Inc. - CONFIDENTIAL
- 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.
Key exclusion criteria (15 listed)
- Evidence of clinically relevant pathology that could interfere with the study results or put the subject's safety at risk.
- Current or recurrent disease that may affect the action, absorption, or disposition of the study treatment, or clinical or laboratory assessments.
- 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.
- History of febrile illness within the 5 days prior to the first dose.
- Positive Hepatitis B surface antigen (HbsAg), Hepatitis C antibody or Human Immunodeficiency Virus (HIV) test result at Screening visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CARD-024Also: 1α-Hydroxy-Vitamin-D5; 1αVitD5Comparison of different dosages of drug | Drug | CARD-024 |
| Drug CarrierAlso: Placebo, Drug CarrierDrug Carrier, 20% ethanol:80% propylene glycol oral administered solution. | Other | Drug Carrier |
Primary outcome
Safety
Time frame: 5 days
Adverse events such as nausea, vomiting, headache, muscle ache, neuralgia and patient overall tolerance to drug.
2 secondary outcomes
Drug Pharmacokinetics
Time frame: 5 days
Drug Pharmacodynamics
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Vanderlugt, MD principal investigator
Jasper Clinic, Michigan
Robert U Simpson, PhD study chair
Cardiavent Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CARD-024 and Drug Carrier in people with Drug Safety and Heart; Disease, Activity, run by Cardiavent Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2012.