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

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ClinicalTrials.gov Identifier: NCT02182271
Recruitment Status : Terminated
First Posted : July 8, 2014
Last Update Posted : July 18, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 201335 ZW - single rising dose Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : October 2004
Actual Primary Completion Date : October 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BI 201335 ZW - single rising dose Drug: BI 201335 ZW - single rising dose
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Number of patients with abnormal findings in physical examination [ Time Frame: Baseline, day 3 of each treatment period, within 8 days after last administration ]
  2. Number of patients with clinically significant changes in vital signs [ Time Frame: Baseline, day 1-3 of each treatment period, within 8 days after last administration ]
  3. Number of patients with clinically significant changes in 12-lead ECG (electrocardiogram) [ Time Frame: Baseline, day 1, 2 in treatment period, within 8 days after last administration ]
  4. Number of patients with abnormal changes in laboratory parameters [ Time Frame: Baseline, day 1-3 of each treatment period, within 8 days after last administration ]
  5. Number of patients with adverse events [ Time Frame: up to 13 days ]
  6. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: on day 3 of each treatment period ]

Secondary Outcome Measures :
  1. Cmax (maximum concentration of the analyte in plasma) [ Time Frame: 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 ]
  2. tmax (time from dosing to maximum concentration) [ Time Frame: 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 ]
  3. AUC0-∞ (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: 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 ]
  4. 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) [ Time Frame: 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 ]
  5. λz (terminal elimination rate constant in plasma) [ Time Frame: 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 ]
  6. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: 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 ]
  7. MRTpo (Mean residence time of the analyte in the body after oral administration) [ Time Frame: 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 ]
  8. CL/F (apparent clearance of the analyte in the plasma after oral administration) [ Time Frame: 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 ]
  9. Vz/F (apparent volume of distribution during the terminal phase λz following an oral dose) [ Time Frame: 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 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02182271     History of Changes
Other Study ID Numbers: 1220.1
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 18, 2014
Last Verified: July 2014