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

NCT02256787 | Completed Phase 1

• 1 other identifier: 1201.1
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (6)

• Number of subjects with abnormal findings in physical examination

  up to 48 hours following drug administration

• Number of subjects with abnormal changes in laboratory parameters

  up to 48 hours following drug administration

• Number of subjects with clinically significant changes in vital signs

  Blood pressure, Pulse Rate

  up to 48 hours following drug administration

• Number of subjects with adverse events

  up to 48 hours following drug administration

• Number of subjects with clinically significant changes in 12-lead ECG (electrocardiogram)

  up to 48 hours following drug administration

• Assessment of tolerability by investigator on a 4-point scale

  after 48 hours following drug administration

Secondary Outcomes (8)

• Cmax (maximum concentration of the analyte in plasma)

  up to 48 hours following drug administration

• tmax (time from dosing to maximum concentration)

  up to 48 hours following drug administration

• AUC0-∞ (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  up to 48 hours following drug administration

• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)

  up to 48 hours following drug administration

• λz (terminal rate constant in plasma)

  up to 48 hours following drug administration

Study Arms (5)

BILB 1941 ZW - single rising dose

EXPERIMENTAL

Single rising dose part

Drug: BILB 1941 ZW - single rising dose part

Placebo

PLACEBO COMPARATOR

Single rising dose part

Drug: Placebo

BILB 1941 ZW - tablet - fasted

EXPERIMENTAL

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

Drug: BILB 1941 ZW - tablet

BILB 1941 ZW - solution

EXPERIMENTAL

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

Drug: BILB 1941 ZW - solution

BILB 1941 ZW - tablet - fed

EXPERIMENTAL

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

Drug: BILB 1941 ZW - tablet; Other: standardized breakfast

Interventions

BILB 1941 ZW - single rising dose part DRUG

BILB 1941 ZW - single rising dose

Placebo DRUG

Placebo

BILB 1941 ZW - solution DRUG

BILB 1941 ZW - solution

BILB 1941 ZW - tablet DRUG

BILB 1941 ZW - tablet - fasted; BILB 1941 ZW - tablet - fed

standardized breakfast OTHER

BILB 1941 ZW - tablet - fed

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• No finding deviating from normal and of clinical relevance
• No evidence of a clinically relevant concomitant disease
• Age ≥18 and Age ≤50 years, BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the 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
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 6, 2014
• Study Start: January 1, 2004
• Primary Completion: September 1, 2004
• Last Updated: October 6, 2014

Record last verified: 2014-10