Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of KUC 7483 CL Tablets in Healthy Male Volunteers

NCT ID: NCT02259764

Last Updated: 2014-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31

Brief Summary

Study to investigate safety, tolerability and pharmacokinetics of KUC 7483 CL

Conditions

Healthy

Study Design

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

Study Groups

KUC 7483 CL - single rising dose

Treatment 1: KUC 7483 CL - low dose

Treatment 2: KUC 7483 CL - medium dose

Treatment 3: KUC 7483 CL - high dose

In treatment 3 the same subjects as in treatment 2 received drug immediately after the ingestion of a standardized high fat meal

Group Type: EXPERIMENTAL

KUC 7483 CL - single rising dose

Intervention Type: DRUG

standardized high fat meal

Intervention Type: OTHER

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

KUC 7483 CL - single rising dose

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

standardized high fat meal

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Healthy males according to the following criteria:

Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead 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 ≥ 30 and Age ≤ 60 years

3. BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)

4. 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

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological 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 (> 10 cigarettes or > 3 cigars of > 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 60 g/day)
• 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 of clinical relevance

The clinical relevance of study parameters will be assessed by the investigator or his deputy

• 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

1207.6

Identifier Type: -

Identifier Source: org_study_id