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

NCT02256722 | Completed Phase 1

• 1 other identifier: 1207.26
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (14)

• Absolute change from baseline in glucose

  up to 24 hours after administration of study drug

• Percentage change from baseline in glucose

  up to 24 hours after administration of study drug

• Absolute change from baseline in free fatty acids (FFA)

  up to 24 hours after administration of study drug

• Percentage change from baseline in FFA

  up to 24 hours after administration of study drug

• Absolute change from baseline in insulin

  up to 24 hours after administration of study drug

• Percentage change from baseline in insulin

  up to 24 hours after administration of study drug

• Absolute change from baseline in C-Peptide

  up to 24 hours after administration of study drug

• Percentage change from baseline in C-Peptide

  up to 24 hours after administration of study drug

• Absolute change from baseline in Potassium

  up to 24 hours after administration of study drug

• Percentage change from baseline in Potassium

  up to 24 hours after administration of study drug

• Absolute change from baseline in Magnesium

  up to 24 hours after administration of study drug

• Percentage change from baseline in Magnesium

  up to 24 hours after administration of study drug

• Absolute change from baseline in cAMP

  up to 24 hours after administration of study drug

• Percentage change from baseline in cAMP

  up to 24 hours after administration of study drug

Secondary Outcomes (8)

• Number of subjects with adverse events

  up to 80 days

• Number of subjects with clinically relevant changes in laboratory tests

  up to 24 hours after administration of study drug

• Number of subjects with clinically relevant changes in vital signs

  up to 24 hours after administration of study drug

• Number of subjects with clinically relevant findings in electrocardiogram

  up to 24 hours after administration of study drug

• Number of subjects with clinically relevant changes in physical examination

  Baseline, within 10 days after last drug administration

Study Arms (5)

Treatment A

EXPERIMENTAL

Drug: KUC 7483 CL

Treatment B

EXPERIMENTAL

Drug: KUC 7483 CL; Drug: Bisoprolol

Treatment C

EXPERIMENTAL

Drug: KUC 7483 CL; Drug: Propranolol

Treatment D

EXPERIMENTAL

Drug: KUC 7483 CL; Drug: Acipimox

Treatment E

ACTIVE COMPARATOR

Drug: Salmeterol

Interventions

KUC 7483 CL DRUG

Treatment A; Treatment B; Treatment C; Treatment D

Bisoprolol DRUG

Treatment B

Propranolol DRUG

Treatment C

Acipimox DRUG

Treatment D

Salmeterol DRUG

Treatment E

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Bisoprolol; Propranolol; acipimox; Salmeterol Xinafoate

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Albuterol; Ethanolamines; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 6, 2014
• Study Start: October 1, 2005
• Primary Completion: November 1, 2005
• Last Updated: October 6, 2014

Record last verified: 2014-10