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Trial record 24 of 50 for:    BI 201335 OR faldaprevir

Assessment of the Effect of BI 201335 on the QT Interval in Healthy Female and Male Subjects

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ClinicalTrials.gov Identifier: NCT02182310
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 June 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2014)
QTcI interval (QT interval individually corrected for heart rate) [ Time Frame: pre-dose and 3 to 8 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02182310 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2014)
  • The mean value of QTcI changes from baseline between 2 h and 24 h after dosing [ Time Frame: Pre dose and 2 to 24 hours post dosing ]
  • The change from mean baseline of the QTcI at any point in time between 2 h and 24 h after dosing [ Time Frame: Pre dose and 2 to 24 hours post dosing ]
  • The time-matched changes versus placebo in QTcI at any point in time between 2 h and 24 h after dosing [ Time Frame: Pre dose and 2 to 24 hours post dosing ]
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 Assessment of the Effect of BI 201335 on the QT Interval in Healthy Female and Male Subjects
Official Title  ICMJE Assessment of the Effect of 480 mg and 1200 mg of BI 201335 as Single Dose on the QT Interval in Healthy Female and Male Subjects. A Randomised, Placebo Controlled, Double-blind, Four-way Crossover Phase-I-study With Moxifloxacin as Positive Control
Brief Summary

To demonstrate that BI 201335 does not prolong the QT interval more than placebo.

To assess the tolerability of 1200 mg of BI 201335 as single dose in female subjects (double-blind, randomised, placebo-controlled) before inclusion of female subjects in the cross-over part of the trial.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: BI 201335 low dose
  • Drug: BI 201335 placebo
  • Drug: Moxifloxacin
  • Drug: BI 201335 high dose
Study Arms  ICMJE
  • Placebo Comparator: BI 201335 placebo
    crossover part
    Intervention: Drug: BI 201335 placebo
  • Experimental: BI 201335 low dose
    crossover part
    Intervention: Drug: BI 201335 low dose
  • Experimental: BI 201335 high dose
    crossover part
    Intervention: Drug: BI 201335 high dose
  • Active Comparator: Moxifloxacin
    crossover part
    Intervention: Drug: Moxifloxacin
  • Experimental: BI 201335 or Placebo
    tolerability part in female subjects
    Interventions:
    • Drug: BI 201335 placebo
    • Drug: BI 201335 high dose
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 7, 2014)
56
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy caucasian males and females, 18 to 50 years of age
  • Body mass index (BMI) ranging from 18.5 to 29.9 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters)
  • Signed written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria:

  • Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (ECG)) deviating from normal and of clinical relevance
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  • History of orthostatic hypotension, fainting spells or blackouts
  • 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 at least one month or less than 10 half-lives of the respective drug before enrolment in the study or during the study
  • Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
  • Participation in another trial with an investigational drug (≤ 30 days prior to administration or during the trial)
  • Heavy smoker (> 10 cigarettes or > 3 cigars of > 3 pipes/day)
  • Inability to refrain from smoking on trial days
  • Alcohol abuse (> 60 g/day)
  • Drug abuse
  • Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
  • Any deviation of a laboratory value that is considered to be of clinical relevance
  • Excessive physical activities within the last week before the trial or during the trial
  • Hypersensitivity to BI 201335, moxifloxacin or related drugs of these classes
  • Homozygous genotype status for "Gilbert" polymorphisms (Uridine diphosphate (UDP)-glucuronosyl transferase 1A1 (UGT1A1)*28, *60)
  • Heart rate at screening of > 85 bpm or < 40 bpm
  • Any screening ECG value outside of the reference range of clinical relevance including, but not limited to pulse rate (PR) interval > 220 ms, QRS interval > 115 ms, QTcB (QT interval, corrected for heart rate according to Bazett's formula) > 470 ms, or QT (uncorrected) > 470 ms
  • For Female subjects

    • Pregnancy
    • Positive pregnancy test
    • No adequate contraception (adequate contraception e.g. sterilisation, intrauterine pressure , oral contraceptives). Females, who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)
    • Inability to maintain this adequate contraception during the whole study period from the time of screening until one month after the last intake
    • Lactation period
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 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 NCT02182310
Other Study ID Numbers  ICMJE 1220.16
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