Single Rising Dose Study of BI 201335 ZW in Healthy Male Subjects

Healthy Clinical Trial

Official title:

Safety, Tolerance, and Pharmacokinetics of Single Oral Doses of 5 mg, 20 mg, 60 mg, 150 mg, 300 mg, 600 mg, 1000 mg, and 1500 mg BI 201335 ZW (PEG 400/TRIS/Water Solution) in Healthy Male Subjects, in a Randomised Double Blind, Placebo Controlled Rising Dose Study, Followed With an Open-label Intra-subject Two-stage Crossover Pilot Bioavailability Comparison of 600 mg BI 201335 ZW in a PEG 400/TRIS/Water Solution Co-administered With Food

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02182271
• Other study ID #: 1220.1
• Status: Terminated
• Phase: Phase 1
• First received: July 2, 2014
• Last updated: July 17, 2014
• Start date: October 2004

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The objective of the current study is to investigate safety, tolerability, and pharmacokinetics of BI 201335 ZW following administration of single rising doses from 5 mg to 1500 mg. In addition Two stage intra-subject bioavailability comparison of 600 mg BI 201335 ZW as a liquid formulation given with and without food.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. primary completion date: October 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy males according to the following criteria based upon a complete medical history, including the physical examination, vital signs ((blood pressure (BP), pulse rate (HR)), 12-lead electrocardiogram (ECG), clinical laboratory tests

• Age =18 and Age =55 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

• Willingness to abstain from alcohol from screening period until conclusion visit

Exclusion Criteria:

• Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance

• Any evidence of a clinically relevant concomitant disease

• 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 2 months 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 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BI 201335 ZW - single rising dose

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with abnormal findings in physical examination		Baseline, day 3 of each treatment period, within 8 days after last administration	No
Primary	Number of patients with clinically significant changes in vital signs		Baseline, day 1-3 of each treatment period, within 8 days after last administration	No
Primary	Number of patients with clinically significant changes in 12-lead ECG (electrocardiogram)		Baseline, day 1, 2 in treatment period, within 8 days after last administration	No
Primary	Number of patients with abnormal changes in laboratory parameters		Baseline, day 1-3 of each treatment period, within 8 days after last administration	No
Primary	Number of patients with adverse events		up to 13 days	No
Primary	Assessment of tolerability by investigator on a 4-point scale		on day 3 of each treatment period	No
Secondary	Cmax (maximum concentration of the analyte in plasma)		pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose	No
Secondary	tmax (time from dosing to maximum concentration)		pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose	No
Secondary	AUC0-8 (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)		pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose	No
Secondary	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)		pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose	No
Secondary	?z (terminal elimination rate constant in plasma)		pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose	No
Secondary	t1/2 (terminal half-life of the analyte in plasma)		pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose	No
Secondary	MRTpo (Mean residence time of the analyte in the body after oral administration)		pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose	No
Secondary	CL/F (apparent clearance of the analyte in the plasma after oral administration)		pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose	No
Secondary	Vz/F (apparent volume of distribution during the terminal phase ?z following an oral dose)		pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 15, 24, 30, 36 and 48 hours post-dose	No

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