HealthyPhase 1NCT01550458
Safety Study of Mibefradil When Given Four Times a Day in Healthy Volunteers
A Phase 1 study testing mibefradil in people with Healthy, run by Cavion, Inc. at 1 site in United States.
Trial summary
The objective of the study is to determine the safety and pharmacokinetics of a 7 day course of oral mibefradil given four times a day in healthy volunteers. This is a dose escalation study in which the total daily dose of mibefradil will be increased with each cohort. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- mibefradil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to 24 Jun 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal healthy volunteers aged 19 to 55 years, male or female, and willing and able to sign informed consent;
- Females must have a negative pregnancy test at screening and be practicing a suitable method of birth control so that, in the opinion of the Investigator, they will not become pregnant during the course of the study, or females can be postmenopausal (no menstrual period for one year) or surgically sterilized. Females must either be sexually inactive (abstinent) for 14 days prior to Screening and remain so through 30 days following the final dosing of the study drug or have been using one of the following acceptable methods of birth control for the times specified:
- Barrier method (condom or diaphragm) with spermicidal for at least 14 days prior to Screening through Day -1 through 30 days following the final dosing of the study drug;
- Surgical sterilization (vasectomy) of partner at least 6 months prior to Day -1; or
- Females of non-childbearing potential have undergone one of the following sterilization procedures at least 6 months prior to Day -1: bilateral tubal ligation, hysterectomy, hysterectomy with unilateral or bilateral oophorectomy, or bilateral oophorectomy.
- Male subjects must continue to use their approved contraceptive method for 60 days after participating in the study.
- Has a body mass index (BMI) between 18.0 and 32.0 kg/m², inclusive; and
- Have no acute illnesses or chronic health issues that require medication.
Who cannot join
- History of investigational drug use within 30 days of this study;
- Subject has a clinically significant disorder that, in the opinion of the Investigator, could result in the subject's inability to understand and comply with the requirements of the study;
- History of hypertension, treated or untreated, or screening BP >140 mm Hg systolic or >90 mm Hg diastolic;
- Currently or within the last 14 days taking any medications (prescription, nonprescription, or herbal or Chinese remedies) including oral contraceptives and hormone replacement therapy;
- Subject has a history of impaired hepatic function that, in the Investigator's opinion, contraindicates participation in this study; or the subject has any other abnormal laboratory value of clinical significance for this study in the Investigators opinion;
- Current smoker (more than 10 cigarettes/day) for 6 months;
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- Subject has a creatinine clearance (CLcr) of less than 70 mL/min as calculated by the
- Cockroft-Gault equation:
- CLcr = ((140 - age) x body mass x [0.85 if female]) / (72 x creatinine)
- where age is given in years, body mass is given in kg, and creatinine is given in mg/dL;
- Subject has a history, signs, or symptoms of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes or other significant underlying cardiovascular disease that are clinically significant in the Investigator's opinion. This includes any known cardiac rhythm disorder or ECG abnormality;
- Subject, in the Investigator's opinion, is likely to have unrecognized cardiovascular disease, based on history or the presence of risk factors;
- Subject is currently taking or had taken in the previous 14 days, herbal preparations containing St. John's Wort (Hypericum perforatum);
- Subject has a history of allergic reactions to calcium channel antagonists;
- Females who are pregnant, actively trying to become pregnant, or lactating. Females must be practicing a suitable method of birth control (adequate barrier method of birth control; abstinence) so that, in the opinion of the Investigator, they will not become pregnant during the course of the study, or females can be postmenopausal (no menstrual period for one year) or surgically sterilized;
- Subject had a recent history (in the past 3 months) suggestive of evidence of alcohol or drug abuse or dependence, or has any unaccounted-for drug or alcohol in the original drug screen (tested positive);
- Allergy to latex or rubber;
- Hemoglobin under laboratory lower limit of normal; or
- Significant blood loss of 500 mL or greater or blood donation within 56 days prior to Day 1. Subjects cannot donate plasma within 5 days prior to Day 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of the Pharmacokinetic and Safety Profile of QID Dosing of Mibefradil in Normal Human Volunteers
The objective of the study is to determine the safety and pharmacokinetics of a 7 day course of oral mibefradil given four times a day in healthy volunteers. This is a dose escalation study in which the total daily dose of mibefradil will be increased with each cohort.
Read the detailed description
This study will establish the safety, detailed pharmacokinetics, and, possibly, maximum tolerated dose (MTD) of ascending doses of mibefradil administered four times a day (QID) in healthy volunteers. The knowledge gained will then guide the details of a study of Interlaced Therapy™ in patients with recurrent High Grade Glioma (HGG). Non-clinical studies are currently on-going in the efficacy of Interlaced Therapy™ in ovarian cancer, pancreatic cancer, and intracranial malignancy.
- Conditions
- Healthy
- Being tested
- mibefradil, Placebo
- Keywords
- Clinical Trial, Phase I, Human Volunteers, Healthy Volunteers, mibefradil, Posicor®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mibefradilDrug
Also called Posicor®, mibefradil dihyrdochloride, RO 40-5967
25 mg tablets for oral administration given for 7 days at a total daily dose beginning at 100 mg per day divided into four doses. Doses will be incremented in successive cohorts by 25 mg/day up to 400 mg/day.
PlaceboOther
Also called sugar pill
1 out of 6 patients per cohort will receive placebo tablets identical in appearance and number to the active mibefradil arm.
| Study group | Role | What they receive |
|---|---|---|
| Mibefradil | Experimental | Not described Receives: Drug: mibefradil |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety of a 7-day course of oral mibefradil in four divided daily doses in normal healthy volunteers.
Safety will be assessed by clinical laboratory tests, physical examinations, vital sign measurements, continuous, real time, 3-lead ECG monitoring, concomitant medication documentation and adverse event monitoring.
Measured: 7 days
Secondary outcomes (2)
Steady State Cmax of Mibefradil
Pharmacokinetics assessments will include the determination of plasma concentrations of mibefradil and its major metabolite. Blood samples will be drawn on Day 1: pre-dose 1, 30 minutes, 1 hr, 2 hr, 3 hr, 4 hr, pre-dose 2, pre-dose 3, pre-dose 4; Day 2: pre-dose 1, pre-dose 3; Day 3: pre-dose 1, pre-dose 3; Day 4: pre-dose 1, 30 minutes, 1 hr, 2 hr, 3 hr, 4 hr, pre-dose 2, pre-dose 3; Day 5: pre-dose 1, pre-dose 3; Day 6: pre-dose 1, pre-dose 3; and Day 7: pre-dose 1, pre-dose 3, pre-dose 4, 30 minutes, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 7 hr, 9 hr after dosing.
Measured: daily for 7 days
Half Life of Mibefradil
Pharmacokinetics assessments will include the determination of plasma concentrations of mibefradil and its major metabolite. Blood samples will be drawn on Day 1: pre-dose 1, 30 minutes, 1 hr, 2 hr, 3 hr, 4 hr, pre-dose 2, pre-dose 3, pre-dose 4; Day 2: pre-dose 1, pre-dose 3; Day 3: pre-dose 1, pre-dose 3; Day 4: pre-dose 1, 30 minutes, 1 hr, 2 hr, 3 hr, 4 hr, pre-dose 2, pre-dose 3; Day 5: pre-dose 1, pre-dose 3; Day 6: pre-dose 1, pre-dose 3; and Day 7: pre-dose 1, pre-dose 3, pre-dose 4, 30 minutes, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 7 hr, 9 hr after dosing.
Measured: daily for 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completion24 Jun 2012
- Study completion24 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cavion, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion, Dana-Farber Cancer Institute, LifeWatch Services, Inc.
- Responsible party
- Sponsor
- Investigators
- Scott Rasmussen, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550458
- Sponsor's protocol ID
- TAU-2011-01
- Status last verified
- Jan 2018
- First submitted
- 29 Feb 2012
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Pharmacokinetic and Safety Profile of QID Dosing of Mibefradil in Normal Human Volunteers
- ClinicalTrials.gov ID
- NCT01550458
- Acronym / sponsor ID
- TAU-2011-01
- Conditions
- Healthy
- Keywords
- Clinical Trial, Phase I, Human Volunteers, Healthy Volunteers, mibefradil, Posicor®
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cavion, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Celerion, Dana-Farber Cancer Institute, LifeWatch Services, Inc.
- Study start
- Feb 2012
- Primary completion
- 24 Jun 2012 (actual)
- Study completion
- 24 Jun 2012 (actual)
- First posted
- 12 Mar 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.
The objective of the study is to determine the safety and pharmacokinetics of a 7 day course of oral mibefradil given four times a day in healthy volunteers. This is a dose escalation study in which the total daily dose of mibefradil will be increased with each cohort.
Detailed description
This study will establish the safety, detailed pharmacokinetics, and, possibly, maximum tolerated dose (MTD) of ascending doses of mibefradil administered four times a day (QID) in healthy volunteers. The knowledge gained will then guide the details of a study of Interlaced Therapy™ in patients with recurrent High Grade Glioma (HGG). Non-clinical studies are currently on-going in the efficacy of Interlaced Therapy™ in ovarian cancer, pancreatic cancer, and intracranial malignancy.
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 |
|---|---|---|
| Mibefradil | Experimental | Drug: mibefradil |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Normal healthy volunteers aged 19 to 55 years, male or female, and willing and able to sign informed consent;
- Females must have a negative pregnancy test at screening and be practicing a suitable method of birth control so that, in the opinion of the Investigator, they will not become pregnant during the course of the study, or females can be postmenopausal (no menstrual period for one year) or surgically sterilized. Females must either be sexually inactive (abstinent) for 14 days prior to Screening and remain so through 30 days following the final dosing of the study drug or have been using one of the following acceptable methods of birth control for the times specified:
- Male subjects must continue to use their approved contraceptive method for 60 days after participating in the study.
- Has a body mass index (BMI) between 18.0 and 32.0 kg/m², inclusive; and
- Have no acute illnesses or chronic health issues that require medication.
Key exclusion criteria (19 listed)
- History of investigational drug use within 30 days of this study;
- Subject has a clinically significant disorder that, in the opinion of the Investigator, could result in the subject's inability to understand and comply with the requirements of the study;
- History of hypertension, treated or untreated, or screening BP >140 mm Hg systolic or >90 mm Hg diastolic;
- Currently or within the last 14 days taking any medications (prescription, nonprescription, or herbal or Chinese remedies) including oral contraceptives and hormone replacement therapy;
- Subject has a history of impaired hepatic function that, in the Investigator's opinion, contraindicates participation in this study; or the subject has any other abnormal laboratory value of clinical significance for this study in the Investigators opinion;
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 |
|---|---|---|
| mibefradilAlso: Posicor®, mibefradil dihyrdochloride, RO 40-596725 mg tablets for oral administration given for 7 days at a total daily dose beginning at 100 mg per day divided into four doses. Doses will be incremented in successive cohorts by 25 mg/day up to 400 mg/day. | Drug | Mibefradil |
| PlaceboAlso: sugar pill1 out of 6 patients per cohort will receive placebo tablets identical in appearance and number to the active mibefradil arm. | Other | Placebo |
Primary outcome
Determine the safety of a 7-day course of oral mibefradil in four divided daily doses in normal healthy volunteers.
Time frame: 7 days
Safety will be assessed by clinical laboratory tests, physical examinations, vital sign measurements, continuous, real time, 3-lead ECG monitoring, concomitant medication documentation and adverse event monitoring.
2 secondary outcomes
Steady State Cmax of Mibefradil
Time frame: daily for 7 days
Half Life of Mibefradil
Time frame: daily for 7 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 8 Apr 2019.
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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.
Scott Rasmussen, MD principal investigator
Celerion
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 mibefradil in people with Healthy, run by Cavion, 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 8 inclusion and 19 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 8 Apr 2019. 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?
Determine the safety of a 7-day course of oral mibefradil in four divided daily doses in normal healthy volunteers. (time frame: 7 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 8 Apr 2019.