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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Moxifloxacin, film-coated tablets; Drug: Placebo, film-coated tablets; Drug: Cilobradine, low, film-coated tablets; Drug: Cilobradine, high, film-coated tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT02264015

503.204

Details and patient eligibility

About

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

Enrollment: 125 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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125 participants in 4 patient groups, including a placebo group

Cilobradine low

Experimental group

Treatment:

Drug: Cilobradine, low, film-coated tablets

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo, film-coated tablets

Moxifloxacin

Active Comparator group

Treatment:

Drug: Moxifloxacin, film-coated tablets

Cilobradine high

Experimental group

Treatment:

Drug: Cilobradine, high, film-coated tablets