HealthyPhase 1NCT02264041
Effect of Cytochrome P 450 3A4 Inhibition by Itraconazole on the Single Oral Dose Pharmacokinetics of Cilobradine
A Phase 1 study testing Cilobradine, low dose, Cilobradine, high dose and Itraconazole in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to investigate the effect of cytochrome P 450 3A4 inhibition by itraconazole on the single dose pharmacokinetics of cilobradine Read more about this study
- Who is it for?
- Ages 21 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cilobradine, low dose, Cilobradine, high dose and Itraconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Apr 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead 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)
- Resting pulse rate (PR; after 10 min. in the supine position) of more than 55 bpm
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice 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
Show all 15Show fewer
- 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 (more than 60 g/day)
- 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
About this study
Official title: The Effect of Cytochrome P 450 3A4 Inhibition by Itraconazole on the Single Oral Dose Pharmacokinetics of Cilobradine (an Open-label, Randomised, Single-dose, Two-way Crossover Study)
Study to investigate the effect of cytochrome P 450 3A4 inhibition by itraconazole on the single dose pharmacokinetics of cilobradine
- Conditions
- Healthy
- Being tested
- Cilobradine, low dose, Cilobradine, high dose, Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cilobradine, low doseDrug
Cilobradine, high doseDrug
ItraconazoleDrug
Also called Sempera®
| Study group | Role | What they receive |
|---|---|---|
| Cilobradine, low dose plus itraconazole | Experimental | Pre-study Receives: Drug: Cilobradine, low dose; Drug: Itraconazole |
| Cilobradine, low dose | Active comparator | Pre-study Receives: Drug: Cilobradine, low dose |
| Cilobradine, high dose plus itraconazole | Experimental | main study Receives: Drug: Cilobradine, high dose; Drug: Itraconazole |
| Cilobradine, high dose | Active comparator | main study Receives: Drug: Cilobradine, high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Measured: up to 56 hours after administration of Cilobradine
Maximum measured concentration of the analyte in plasma (Cmax)
Measured: up to 56 hours after administration of Cilobradine
Secondary outcomes (15)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)
Measured: up to 56 hours after administration of Cilobradine
Time from dosing to Cmax (Tmax)
Measured: up to 56 hours after administration of Cilobradine
Terminal rate constant in plasma (λz)
Measured: up to 56 hours after administration of Cilobradine
Terminal half-life of the analyte in plasma (t1/2)
Measured: up to 56 hours after administration of Cilobradine
Mean residence time of the analyte in the body after p.o. administration (MRTpo)
Measured: up to 56 hours after administration of Cilobradine
Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)
Measured: up to 56 hours after administration of Cilobradine
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
Measured: up to 56 hours after administration of Cilobradine
Amount of parent compound excreted in urine with zero to 72 h in % of dose (fe0-tz)
Measured: up to 72 hours after administration of Cilobradine
Renal clearance of cilobradine (CLR,0-tz)
Measured: up to 72 hours after administration of Cilobradine
Number of subjects with adverse events
Measured: up to 46 days
Occurrence of visual phenomena
questionnaire
Measured: up to 46 days
Number of subjects with clinically relevant findings in vital signs
blood pressure, pulse rate
Measured: up to 32 days
Number of subjects with clinically relevant findings in laboratory tests
Measured: up to 32 days
Number of subjects with clinically relevant findings in 12-lead electrocardiogram
Measured: up to 32 days
Assessment of tolerability by investigator on a 4-point scale
Measured: within 8 days after last PK sampling
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 completionApr 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT02264041
- Sponsor's protocol ID
- 503.213
- 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
- The Effect of Cytochrome P 450 3A4 Inhibition by Itraconazole on the Single Oral Dose Pharmacokinetics of Cilobradine (an Open-label, Randomised, Single-dose, Two-way Crossover Study)
- ClinicalTrials.gov ID
- NCT02264041
- Acronym / sponsor ID
- 503.213
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Apr 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.
Study to investigate the effect of cytochrome P 450 3A4 inhibition by itraconazole on the single dose pharmacokinetics of cilobradine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cilobradine, low dose plus itraconazole | Experimental | Drug: Cilobradine, low dose, Drug: ItraconazolePre-study |
| Cilobradine, low dose | Active comparator | Drug: Cilobradine, low dosePre-study |
| Cilobradine, high dose plus itraconazole | Experimental | Drug: Cilobradine, high dose, Drug: Itraconazolemain study |
| Cilobradine, high dose | Active comparator | Drug: Cilobradine, high dosemain study |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy males according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead 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 (15 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 dose | Drug | Cilobradine, low dose, Cilobradine, low dose plus itraconazole |
| Cilobradine, high dose | Drug | Cilobradine, high dose, Cilobradine, high dose plus itraconazole |
| ItraconazoleAlso: Sempera® | Drug | Cilobradine, high dose plus itraconazole, Cilobradine, low dose plus itraconazole |
Primary outcome
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: up to 56 hours after administration of Cilobradine
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: up to 56 hours after administration of Cilobradine
15 secondary outcomes
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)
Time frame: up to 56 hours after administration of Cilobradine
Time from dosing to Cmax (Tmax)
Time frame: up to 56 hours after administration of Cilobradine
Terminal rate constant in plasma (λz)
Time frame: up to 56 hours after administration of Cilobradine
Terminal half-life of the analyte in plasma (t1/2)
Time frame: up to 56 hours after administration of Cilobradine
Mean residence time of the analyte in the body after p.o. administration (MRTpo)
Time frame: up to 56 hours after administration of Cilobradine
Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)
Time frame: up to 56 hours after administration of Cilobradine
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
Time frame: up to 56 hours after administration of Cilobradine
Amount of parent compound excreted in urine with zero to 72 h in % of dose (fe0-tz)
Time frame: up to 72 hours after administration of Cilobradine
Renal clearance of cilobradine (CLR,0-tz)
Time frame: up to 72 hours after administration of Cilobradine
Number of subjects with adverse events
Time frame: up to 46 days
Occurrence of visual phenomena
Time frame: up to 46 days
Number of subjects with clinically relevant findings in vital signs
Time frame: up to 32 days
Number of subjects with clinically relevant findings in laboratory tests
Time frame: up to 32 days
Number of subjects with clinically relevant findings in 12-lead electrocardiogram
Time frame: up to 32 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: within 8 days after last PK sampling
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 dose, Cilobradine, high dose and Itraconazole 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 8 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 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. 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?
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) (time frame: up to 56 hours after administration of Cilobradine). 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.