HealthyPhase 1NCT02264015
Pharmacodynamic Effects, Safety and Tolerability of Cilobradine, to Healthy Male and Female Volunteers, With an Intra-individual Comparison to Moxifloxacin in a Subset of Volunteers
A Phase 1 study testing Cilobradine, low, film-coated tablets, Cilobradine, high, film-coated tablets and Moxifloxacin, film-coated tablets in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Incidence of visual phenomena, heart rate at rest, safety (with particular emphasis on QT analysis of ECGs), and pharmacokinetic parameters Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cilobradine, low, film-coated tablets, Cilobradine, high, film-coated tablets and Moxifloxacin, film-coated tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to May 2004
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests
- 1.1 No finding deviating from normal and of clinical relevance
- 1.2 No evidence of a clinically relevant concomitant disease
- Age ≥21 and Age ≤55 years
- BMI ≥18.5 and BMI < 30 kg/m2 (Body Mass Index)
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- Resting Heart rate (HR) (after 10 min. in the supine position) of equal or more than 60 bpm
- Females: post-menopausal or those who have had a hysterectomy (plus a negative pregnancy test)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
Who cannot join
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, ophthalmological, or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
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- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance.
- Subjects at increased risk for development of cardiac arrhythmia (e.g. family history of long QT syndrome or sudden cardiac death)
About this study
Official title: Pharmacodynamic Effects, Safety and Tolerability of 2 mg and 5 mg Cilobradine, Administered p.o. Once Daily Over 14 Days to Healthy Male and Female Volunteers in a Randomised, Placebo-controlled, Double Blind Study, With an Open-label Uncontrolled Intra-individual Comparison to 400 mg Moxifloxacin Single Dose in a Subset of Volunteers.
Incidence of visual phenomena, heart rate at rest, safety (with particular emphasis on QT analysis of ECGs), and pharmacokinetic parameters
- Conditions
- Healthy
- Being tested
- Cilobradine, low, film-coated tablets, Cilobradine, high, film-coated tablets, Placebo, film-coated tablets, Moxifloxacin, film-coated tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cilobradine, low, film-coated tabletsDrug
Cilobradine, high, film-coated tabletsDrug
Placebo, film-coated tabletsDrug
Moxifloxacin, film-coated tabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| Cilobradine low | Experimental | Not described Receives: Drug: Cilobradine, low, film-coated tablets |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo, film-coated tablets |
| Moxifloxacin | Active comparator | Not described Receives: Drug: Moxifloxacin, film-coated tablets |
| Cilobradine high | Experimental | Not described Receives: Drug: Cilobradine, high, film-coated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of visual phenomena
Reported as adverse events
Measured: Up to 12 days after last scheduled study day
Change in heart rate at rest
Measured: Pre dose, up to 12 hours after drug administration
Secondary outcomes (14)
Investigator assessed tolerability on a 4 point scale
Measured: Up to 12 days after last scheduled study day
Number of participants with abnormal findings in physical examination
Measured: Up to 12 days after last scheduled study day
Number of participants with clinically significant changes in vital signs
Measured: Up to 12 days after last scheduled study day
Number of participants with adverse events
Measured: Up to 12 days after last scheduled study day
Characteristics of visual phenomena on a special questionnaire
Measured: Up to 12 days after last scheduled study day
Number of participants with abnormal changes in clinical laboratory parameters
Measured: Up to 12 days after last scheduled study day
Number of participants with abnormal findings in electrocardiogram (ECG)
Measured: Up to 12 days after last scheduled study day
Area under the concentration-time curve of the analyte in plasma from zero time to 24 hours (AUC0-24)
Measured: Up to 24 hours after drug administration
Maximum plasma concentration following the first dose (Cmax)
Measured: Up to 24 hours after drug administration
Time from first dose to the maximum plasma concentration (tmax)
Measured: Up to 24 hours after drug administration
Terminal half-life (t1/2)
Measured: Up to 24 hours after drug administration
Mean residence time of the analyte in the body after oral administration (MRTpo)
Measured: Up to 24 hours after drug administration
Apparent clearance of the analyte in plasma following extravascular administration (CL/F)
Measured: Up to 24 hours after drug administration
Apparent volume of distribution during the terminal phase λz following extravascular administration (Vz/F)
Measured: Up to 24 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startJan 2004
- Primary completionMay 2004
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.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- Double blind
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264015
- Sponsor's protocol ID
- 503.204
- Status last verified
- Oct 2014
- First submitted
- 13 Oct 2014
- Last updated
- 15 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic Effects, Safety and Tolerability of 2 mg and 5 mg Cilobradine, Administered p.o. Once Daily Over 14 Days to Healthy Male and Female Volunteers in a Randomised, Placebo-controlled, Double Blind Study, With an Open-label Uncontrolled Intra-individual Comparison to 400 mg Moxifloxacin Single Dose in a Subset of Volunteers.
- ClinicalTrials.gov ID
- NCT02264015
- Acronym / sponsor ID
- 503.204
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- May 2004 (actual)
- First posted
- 15 Oct 2014 (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.
Incidence of visual phenomena, heart rate at rest, safety (with particular emphasis on QT analysis of ECGs), and pharmacokinetic parameters
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cilobradine low | Experimental | Drug: Cilobradine, low, film-coated tablets |
| Placebo | Placebo comparator | Drug: Placebo, film-coated tablets |
| Moxifloxacin | Active comparator | Drug: Moxifloxacin, film-coated tablets |
| Cilobradine high | Experimental | Drug: Cilobradine, high, film-coated tablets |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy males and females according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests
- 1.1 No finding deviating from normal and of clinical relevance
- 1.2 No evidence of a clinically relevant concomitant disease
- Age ≥21 and Age ≤55 years
Key exclusion criteria (16 listed)
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, ophthalmological, or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
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 |
|---|---|---|
| Cilobradine, low, film-coated tablets | Drug | Cilobradine low |
| Cilobradine, high, film-coated tablets | Drug | Cilobradine high |
| Placebo, film-coated tablets | Drug | Placebo |
| Moxifloxacin, film-coated tablets | Drug | Moxifloxacin |
Primary outcome
Incidence of visual phenomena
Time frame: Up to 12 days after last scheduled study day
Reported as adverse events
Change in heart rate at rest
Time frame: Pre dose, up to 12 hours after drug administration
14 secondary outcomes
Investigator assessed tolerability on a 4 point scale
Time frame: Up to 12 days after last scheduled study day
Number of participants with abnormal findings in physical examination
Time frame: Up to 12 days after last scheduled study day
Number of participants with clinically significant changes in vital signs
Time frame: Up to 12 days after last scheduled study day
Number of participants with adverse events
Time frame: Up to 12 days after last scheduled study day
Characteristics of visual phenomena on a special questionnaire
Time frame: Up to 12 days after last scheduled study day
Number of participants with abnormal changes in clinical laboratory parameters
Time frame: Up to 12 days after last scheduled study day
Number of participants with abnormal findings in electrocardiogram (ECG)
Time frame: Up to 12 days after last scheduled study day
Area under the concentration-time curve of the analyte in plasma from zero time to 24 hours (AUC0-24)
Time frame: Up to 24 hours after drug administration
Maximum plasma concentration following the first dose (Cmax)
Time frame: Up to 24 hours after drug administration
Time from first dose to the maximum plasma concentration (tmax)
Time frame: Up to 24 hours after drug administration
Terminal half-life (t1/2)
Time frame: Up to 24 hours after drug administration
Mean residence time of the analyte in the body after oral administration (MRTpo)
Time frame: Up to 24 hours after drug administration
Apparent clearance of the analyte in plasma following extravascular administration (CL/F)
Time frame: Up to 24 hours after drug administration
Apparent volume of distribution during the terminal phase λz following extravascular administration (Vz/F)
Time frame: Up to 24 hours after drug administration
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 15 Oct 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cilobradine, low, film-coated tablets, Cilobradine, high, film-coated tablets and Moxifloxacin, film-coated tablets in people with Healthy, run by Boehringer Ingelheim.
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 9 inclusion and 16 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 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of visual phenomena (time frame: Up to 12 days after last scheduled study day). The study lists 2 primary outcomes in all. 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 15 Oct 2014.