In Vivo Specificity of KUC 7483 CL Co-administered With Bisoprolol, Propranolol, and Acipimox in Healthy Male Subjects

NCT ID: NCT02256722

Last Updated: 2014-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31

Brief Summary

Study to compare the metabolic and electrolyte effects of a single oral dose of 320 mg ritobegron administered alone or with a pre- and comedication with bisoprolol, propranolol and acipimox. In addition, to compare the metabolic and electrolyte effects of a single dose of 320 mg ritobegron with those of a single inhalatory dose of 100 μg salmeterol

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment A

Group Type: EXPERIMENTAL

KUC 7483 CL

Intervention Type: DRUG

Treatment B

Group Type: EXPERIMENTAL

KUC 7483 CL

Intervention Type: DRUG

Bisoprolol

Intervention Type: DRUG

Treatment C

Group Type: EXPERIMENTAL

KUC 7483 CL

Intervention Type: DRUG

Propranolol

Intervention Type: DRUG

Treatment D

Group Type: EXPERIMENTAL

KUC 7483 CL

Intervention Type: DRUG

Acipimox

Intervention Type: DRUG

Treatment E

Group Type: ACTIVE_COMPARATOR

Salmeterol

Intervention Type: DRUG

Interventions

KUC 7483 CL

Intervention Type: DRUG

Bisoprolol

Intervention Type: DRUG

Propranolol

Intervention Type: DRUG

Acipimox

Intervention Type: DRUG

Salmeterol

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male
• Age >= 30 and <= 60 years
• Body Mass Index (BMI) >= 18.5 and <= 29.9 kg/m2
• Signed and dated written informed consent in accordance with Good Clinical Practice and local legislation

Exclusion Criteria

• Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, clinically relevant electrolyte disturbances
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of orthostatic hypotension, fainting spells or blackouts
• Chronic or clinically 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 (> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
• Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
• Participation in another trial with an investigational drug (within 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)
• Any laboratory value outside the reference range if indicative of underlying disease or poor health
• Excessive physical activities within the last week before the trial or during the trial
• Hypersensitivity to treatment medication, salmeterol and/or related drugs of these classes
• Congenital or documented acquired QT- prolongation, previous history of symptomatic arrhythmias
• Systolic BP < 115 mmHg
• Heart rate at rest of > 80 bpm or < 55 bpm
• Any screening ECG value outside of the reference range of clinical relevance including, but not limited to PR interval > 220 ms, QRS interval > 115 ms, QTcB > 420 ms, or QT (uncorrected) > 450 ms
• History of asthma or obstructive pulmonary disease.
• Psoriasis (own medical history or relative)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1207.26

Identifier Type: -

Identifier Source: org_study_id