Safety, Tolerance, and Pharmacokinetics of Single Rising Oral Doses of BILB 1941 ZW Solution in Healthy Male Subjects, Followed With Bioavailability Comparison of BILB 1941 ZW Tablet and Solution Formulation Administered With or Without Food

NCT ID: NCT02256787

Last Updated: 2014-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31

Brief Summary

The objective of the current study was to investigate the safety, tolerability, and pharmacokinetics of BILB 1941 ZW following the administration of single rising doses from 5 mg to 300 mg. In addition the bioavailability of the 60 mg dose given fasted and after a high-fat breakfast was to be be investigated

Conditions

Healthy

Study Design

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

Study Groups

BILB 1941 ZW - single rising dose

Single rising dose part

Group Type: EXPERIMENTAL

BILB 1941 ZW - single rising dose part

Intervention Type: DRUG

Placebo

Single rising dose part

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

BILB 1941 ZW - tablet - fasted

Relative bioavailability: The oral solution fasted should be compared with the solid form fasted and after a standardized breakfast

Group Type: EXPERIMENTAL

BILB 1941 ZW - tablet

Intervention Type: DRUG

BILB 1941 ZW - solution

Relative bioavailability: The oral solution fasted should be compared with the solid form fasted and after a standardized breakfast

Group Type: EXPERIMENTAL

BILB 1941 ZW - solution

Intervention Type: DRUG

BILB 1941 ZW - tablet - fed

Relative bioavailability: The oral solution fasted should be compared with the solid form fasted and after a standardized breakfast

Group Type: EXPERIMENTAL

BILB 1941 ZW - tablet

Intervention Type: DRUG

standardized breakfast

Intervention Type: OTHER

Interventions

BILB 1941 ZW - single rising dose part

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

BILB 1941 ZW - solution

Intervention Type: DRUG

BILB 1941 ZW - tablet

Intervention Type: DRUG

standardized breakfast

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 ≥18 and Age ≤50 years, BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)

3. 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

• Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders, including a clinical history of viral hepatitis, or serological evidence of active Hepatitis B or Hepatitis C infection
• History of orthostatic hypotension, fainting spells and blackouts
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• 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 1 month prior to administration
• Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within 1 month prior to administration or during the trial
• Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on trial days
• Alcohol abuse (> 60 g/day)
• Drug abuse
• Blood donation of more than 100 mL within 1 month prior to administration or during the trial
• Excessive physical activities within 5 days prior to administration or during the trial
• Any laboratory value outside the clinically accepted reference range and of clinical relevance
• History of any familial bleeding disorder

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1201.1

Identifier Type: -

Identifier Source: org_study_id