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

NCT ID: NCT02264015

Last Updated: 2014-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cilobradine low

Group Type: EXPERIMENTAL

Cilobradine, low, film-coated tablets

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo, film-coated tablets

Intervention Type: DRUG

Moxifloxacin

Group Type: ACTIVE_COMPARATOR

Moxifloxacin, film-coated tablets

Intervention Type: DRUG

Cilobradine high

Group Type: EXPERIMENTAL

Cilobradine, high, film-coated tablets

Intervention Type: DRUG

Interventions

Cilobradine, low, film-coated tablets

Intervention Type: DRUG

Cilobradine, high, film-coated tablets

Intervention Type: DRUG

Placebo, film-coated tablets

Intervention Type: DRUG

Moxifloxacin, film-coated tablets

Intervention Type: DRUG

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.

16. Subjects at increased risk for development of cardiac arrhythmia (e.g. family history of long QT syndrome or sudden cardiac death)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

503.204

Identifier Type: -

Identifier Source: org_study_id