Clinical trial NCT02264015: 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
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-15
Enrollment: 125
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Incidence of visual phenomena, heart rate at rest, safety (with particular emphasis on QT analysis of ECGs), and pharmacokinetic parameters


Eligibility criteria: Inclusion Criteria:

1. 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
2. Age ≥21 and Age ≤55 years
3. BMI ≥18.5 and BMI \< 30 kg/m2 (Body Mass Index)
4. Resting Heart rate (HR) (after 10 min. in the supine position) of equal or more than 60 bpm
5. Females: post-menopausal or those who have had a hysterectomy (plus a negative pregnancy test)
6. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, ophthalmological, or hormonal disorders
2. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
3. History of relevant orthostatic hypotension, fainting spells or blackouts
4. Chronic or relevant acute infections
5. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
6. 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
7. 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
8. Participation in another trial with an investigational drug within two months prior to administration or during the trial
9. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
10. Inability to refrain from smoking on trial days
11. Alcohol abuse
12. Drug abuse
13. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
14. Excessive physical activities (within one week prior to administration or during the trial)
15. Any laboratory value outside the reference range that is of clinical relevance.

    Exclusion criteria specific for this study:
16. Subjects at increased risk for development of cardiac arrhythmia (e.g. family history of long QT syndrome or sudden cardiac death)

Primary outcomes:
measure: Incidence of visual phenomena
timeFrame: Up to 12 days after last scheduled study day
measure: Change in heart rate at rest
timeFrame: Pre dose, up to 12 hours after drug administration
Secondary outcomes:
measure: Investigator assessed tolerability on a 4 point scale
timeFrame: Up to 12 days after last scheduled study day
measure: Number of participants with abnormal findings in physical examination
timeFrame: Up to 12 days after last scheduled study day
measure: Number of participants with clinically significant changes in vital signs
timeFrame: Up to 12 days after last scheduled study day
measure: Number of participants with adverse events
timeFrame: Up to 12 days after last scheduled study day
measure: Characteristics of visual phenomena on a special questionnaire
timeFrame: Up to 12 days after last scheduled study day
measure: Number of participants with abnormal changes in clinical laboratory parameters
timeFrame: Up to 12 days after last scheduled study day
measure: Number of participants with abnormal findings in electrocardiogram (ECG)
timeFrame: Up to 12 days after last scheduled study day
measure: Area under the concentration-time curve of the analyte in plasma from zero time to 24 hours (AUC0-24)
timeFrame: Up to 24 hours after drug administration
measure: Maximum plasma concentration following the first dose (Cmax)
timeFrame: Up to 24 hours after drug administration
measure: Time from first dose to the maximum plasma concentration (tmax)
timeFrame: Up to 24 hours after drug administration
measure: Terminal half-life (t1/2)
timeFrame: Up to 24 hours after drug administration
measure: Mean residence time of the analyte in the body after oral administration (MRTpo)
timeFrame: Up to 24 hours after drug administration
measure: Apparent clearance of the analyte in plasma following extravascular administration (CL/F)
timeFrame: Up to 24 hours after drug administration
measure: Apparent volume of distribution during the terminal phase λz following extravascular administration (Vz/F)
timeFrame: Up to 24 hours after drug administration
Other outcomes:
Locations:
Study officials:
References: