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Pharmacodynamic Effects, Safety and Tolerability of Cilobradine, Compared to Metoprolol Succinate and Placebo in Healthy Volunteers

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Cilobradine low dose 1 (Drug); Cilobradine low dose 2 (Drug); Cilobradine medium dose (Drug); Cilobradine high dose 1 (Drug); Cilobradine high dose 2 (Drug); Metoprolol succinate tablets (Drug); Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Boehringer Ingelheim

Summary

Pharmacodynamic effects on heart rate (HR) at rest and during exercise and on flicker fusion frequency (FFF), FFF method evaluation Safety, tolerability and pharmacokinetics of cilobradine

Clinical Details

Official title: Pharmacodynamic Effects, Safety and Tolerability of 0.25 mg, 0.5 mg, 1 mg and 2 mg Cilobradine, Compared to 190 mg Metoprolol Succinate and Placebo, Administered p.o. Once Daily Over 14 Days to Healthy Volunteers in a Randomised, Placebo-controlled, Partly Double Blind Study, With a 4 mg/14 mg and 10 mg/20 mg Cilobradine Single Dose Versus Placebo Substudy (Double Blind, Three-fold Cross-over)

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

Changes in heart rate at rest

Changes in heart rate during exercise

Changes in flicker fusion frequency test (FFF)

Secondary outcome:

Number of patients with clinically relevant changes in laboratory tests

Number of patients with clinically relevant changes in vital signs (blood pressure, heart rate)

Number of patients with clinically relevant changes in 12-lead ECG

Number of patients with adverse events

Assessment of global tolerability by the investigator

Changes in peripheral FFF

Area under the concentration-time curve of the analytes in plasma (AUC)

Maximum measured concentration of the analytes in plasma (Cmax)

Time from dosing to the maximum concentration of the analytes in plasma (tmax)

Terminal half-life of the analytes in plasma (t½)

Mean residence time of the analytes in the body after oral administration (MRTpo)

Total clearance of the analytes in plasma following extravascular administration (CL/F)

Apparent volume of distribution of the analytes during the terminal phase λz following extravascular administration (Vz/F)

Eligibility

Minimum age: 21 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- All participants in the study should be healthy males and females. Volunteers will

- be 21 to 55 years of age

- have a Body Mass Index (BMI) of 19. 9 to 29. 9 kg/m2 and

- have a resting heart rate (HR) (after 10 min. in the supine position) of more

than 55 beats per minute (bpm)

- Only post-menopausal females, or those who had had a hysterectomy, could participate.

All females had to have a negative pregnancy test

- In accordance with good clinical practice (GCP) and the local legislation all

volunteers had to give their written informed consent prior to admission to the study Exclusion Criteria:

- Any finding of the medical examination (including BP, HR and ECG) deviating from

normal and of clinical relevance

- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,

immunological or hormonal disorders

- Diseases of the central nervous system 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 ten half-lives of the

respective drug before enrolment in the study

- Use of any drugs which might influence the results of the trial within two weeks

prior to administration or during the trial

- Participation in another trial with an investigational drug (≤ two months prior to

administration or during the trial)

- Smoker (> 10 cigarettes or > 3 cigars of > 3 pipes/day)

- Inability to refrain from smoking on trial days

- Alcohol abuse (> 60 g/day)

- Drug abuse

- Blood donation (≥ 100 ml within four weeks prior to administration or during the

trial)

- Excessive physical activities (within the last week before the study)

- Any laboratory value outside the reference range of clinical relevance

Not necessarily clinically relevant abnormalities, but specific Exclusion criteria for the drugs under study or for the study:

- Consumption of more than 2 cups of coffee or black tea, or cola drinks, per day

during the last 6 weeks. However, subjects may participate if abstinence from the before mentioned beverages is well tolerated during an interval of at least 2 weeks between screening and first treatment

- ECG: PQ interval > 210 ms

- HR at rest < 55 bpm

- Systolic BP < 115 mmHg

- Colour vision test abnormal. However, subjects may participate if they are able to

perform the flicker fusion test without difficulty

- Psoriasis (own medical history or relative)

- Relevant ophthalmological disease

- History of asthma or obstructive pulmonary disease

- History (including childhood) of traumatic injury to the head or brain

- History (including childhood) of reduced seizure threshold

- The following subjects will not be allowed to participate in the study

- Any subject involved in professional transportation of human subjects

- Any subject involved in operating dangerous machinery

Locations and Contacts

Additional Information

Starting date: February 2003
Last updated: October 13, 2014

Page last updated: August 23, 2015

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