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

NCT02264015 | Completed Phase 1

• 1 other identifier: 503.204
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Incidence of visual phenomena

  Reported as adverse events

  Up to 12 days after last scheduled study day

• Change in heart rate at rest

  Pre dose, up to 12 hours after drug administration

Secondary Outcomes (14)

• Investigator assessed tolerability on a 4 point scale

  Up to 12 days after last scheduled study day

• Number of participants with abnormal findings in physical examination

  Up to 12 days after last scheduled study day

• Number of participants with clinically significant changes in vital signs

  Up to 12 days after last scheduled study day

• Number of participants with adverse events

  Up to 12 days after last scheduled study day

• Characteristics of visual phenomena on a special questionnaire

  Up to 12 days after last scheduled study day

Study Arms (4)

Cilobradine low

EXPERIMENTAL

Drug: Cilobradine, low, film-coated tablets

Placebo

PLACEBO COMPARATOR

Drug: Placebo, film-coated tablets

Moxifloxacin

ACTIVE COMPARATOR

Drug: Moxifloxacin, film-coated tablets

Cilobradine high

EXPERIMENTAL

Drug: Cilobradine, high, film-coated tablets

Interventions

Cilobradine, low, film-coated tablets DRUG

Cilobradine low

Cilobradine, high, film-coated tablets DRUG

Cilobradine high

Placebo, film-coated tablets DRUG

Placebo

Moxifloxacin, film-coated tablets DRUG

Moxifloxacin

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• No finding deviating from normal and of clinical relevance
• 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 Heart rate (HR) (after 10 min. in the supine position) of equal or more than 60 bpm
• Females: post-menopausal or those who have had a hysterectomy (plus a negative pregnancy test)
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

You may not qualify if:

• 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
• 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
• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

cilobradine; Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2014
• First Posted: October 15, 2014
• Study Start: January 1, 2004
• Primary Completion: May 1, 2004
• Last Updated: October 15, 2014

Record last verified: 2014-10