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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Other: standardized high fat meal; Drug: KUC 7483 CL - single rising dose; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02259764

1207.6

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Male

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

24 participants in 2 patient groups, including a placebo group

KUC 7483 CL - single rising dose

Experimental group

Description:

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

Treatment:

Other: standardized high fat meal

Drug: KUC 7483 CL - single rising dose

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo