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Trial record 13 of 50 for:    BI 201335 OR faldaprevir

Safety, Tolerability, and Pharmacokinetics of BI 201335 NA in Healthy Male Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02182297
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 18, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE July 2, 2014
First Posted Date  ICMJE July 8, 2014
Last Update Posted Date July 18, 2014
Study Start Date  ICMJE April 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2014)
  • Number of patients with abnormal findings in physical examination [ Time Frame: Baseline and within 7 days after last trial procedure ]
  • Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate) [ Time Frame: Baseline, pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose and day 12 ]
  • Number of patients with abnormal findings in 12-lead electrocardiography (ECG) [ Time Frame: Baseline, pre-dose and 1, 2, 4, 6, 8, 24, 48, 72 and 96 hours post-dose and day 12 ]
  • Number of patients with abnormal changes in laboratory tests (haematology, clinical chemistry, and urinalysis) [ Time Frame: Baseline, pre-dose and 24, 48, 72 and 96 hours post-dose and day 12 ]
  • Number of patients with adverse events [ Time Frame: up to day 12 ]
  • Assessment of tolerability by the investigator on a 4-point scale [ Time Frame: day 12 (within 7 days after last trial procedure) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02182297 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2014)
  • Cmax (maximum concentration of the analyte in plasma) [ Time Frame: pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose ]
  • tmax (time from dosing to maximum concentration of the analyte in plasma) [ Time Frame: pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose ]
  • 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 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose ]
  • 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 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose ]
  • λz (terminal elimination rate constant in plasma) [ Time Frame: pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose ]
  • t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose ]
  • MRTpo (mean residence time of the analyte in the body after po administration) [ Time Frame: pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose ]
  • CL/F (apparent clearance of the analyte in the plasma after oral administration) [ Time Frame: pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose ]
  • Vz/F (apparent volume of distribution during the terminal phase λz following an oral administration) [ Time Frame: pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose ]
  • Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2) [ Time Frame: 0-4, 4-12, 12-24, 24-48, 48-72 and 72-96 hours post-dose ]
  • fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) [ Time Frame: 0-4, 4-12, 12-24, 24-48, 48-72 and 72-96 hours post-dose ]
  • CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) [ Time Frame: 0-4, 4-12, 12-24, 24-48, 48-72 and 72-96 hours post-dose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, and Pharmacokinetics of BI 201335 NA in Healthy Male Subjects
Official Title  ICMJE Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses (40 mg to 480 mg) of BI 201335 NA as Capsule(s) Administered to Healthy Male Subjects - a Randomised, Placebo-controlled (Within Dose Groups) and Double-blind Trial
Brief Summary The objective of this trial was to investigate safety, tolerability, and pharmacokinetics of BI 201335 ZW after administration of single rising doses from 40 mg to 480 mg of BI 201335 NA in healthy Japanese male volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: BI 201335 NA in single rising doses
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: BI 201335 NA in single rising doses
    Intervention: Drug: BI 201335 NA in single rising doses
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2014)
50
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects will be healthy male volunteers who meet the criteria below:

  • Persons without clinically remarkable findings or clinically evident complications based on their concurrent illness, past medical history, physical examination, vital signs (blood pressure, pulse rate, and body temperature), 12-lead ECG, and laboratory test results
  • Persons who are 20 or older and 35 or younger
  • Persons with body mass index (BMI) of 18.5 kg/m2 or more and 25.0 kg/m2 less
  • Persons who are willing to participate in this trial before study initiation and who give their written consent in accordance with the GCP (Good Clinical Practice)

Exclusion Criteria:

  • Any finding of the medical examination (including blood pressure, pulse rate, body temperature, and ECG) deviating from normal and of clinical relevance
  • Any evidence of a clinically relevant concomitant disease
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
  • Prior history of jaundice
  • Surgery of the gastrointestinal tract (except appendectomy)
  • 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 relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  • Intake of drugs with a long half-life (>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to administration or during the trial
  • Use of any drugs within 10 days prior to administration or during the trial
  • Participation in another trial with an investigational product within four months prior to administration or during the trial
  • Smoker (>10 cigarettes, >3 cigars or >3 pipes/day)
  • Inability to refrain from smoking on trial days (during hospitalisation and end of trial)
  • Alcohol abuse (more than 60 g/day)
  • Drug abuse
  • Blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
  • Excessive physical activities (within 1 week prior to administration or during the trial)
  • Any laboratory value outside the reference range that is of clinical relevance
  • Inability to comply with dietary regimen of the trial site
  • A history of additional risk factors for torsades de pointe (e.g., heart failure, hypokalemia, and family history of long QT syndrome)
  • The use of concomitant medications that prolong the QT/corrected QT interval
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02182297
Other Study ID Numbers  ICMJE 1220.13
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP