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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

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.


Condition or disease Intervention/treatment Phase
Healthy Drug: BI 201335 low dose Drug: BI 201335 placebo Drug: Moxifloxacin Drug: BI 201335 high dose Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2008
Actual Primary Completion Date : October 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: BI 201335 placebo
crossover part
Drug: BI 201335 placebo
Experimental: BI 201335 low dose
crossover part
Drug: BI 201335 low dose
Experimental: BI 201335 high dose
crossover part
Drug: BI 201335 high dose
Active Comparator: Moxifloxacin
crossover part
Drug: Moxifloxacin
Experimental: BI 201335 or Placebo
tolerability part in female subjects
Drug: BI 201335 placebo
Drug: BI 201335 high dose



Primary Outcome Measures :
  1. QTcI interval (QT interval individually corrected for heart rate) [ Time Frame: pre-dose and 3 to 8 hours ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02182310     History of Changes
Other Study ID Numbers: 1220.16
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 18, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
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Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs