Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 201335 placebo | Placebo Comparator | crossover part |
|
| BI 201335 low dose | Experimental | crossover part |
|
| BI 201335 high dose | Experimental | crossover part |
|
| Moxifloxacin | Active Comparator | crossover part |
|
| BI 201335 or Placebo | Experimental | tolerability part in female subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 201335 low dose | Drug |
| ||
| BI 201335 placebo |
| Measure | Description | Time Frame |
|---|---|---|
| QTcI interval (QT interval individually corrected for heart rate) | pre-dose and 3 to 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The mean value of QTcI changes from baseline between 2 h and 24 h after dosing | 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 | Pre dose and 2 to 24 hours post dosing |
Not provided
Inclusion Criteria:
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
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C552340 | faldaprevir |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Moxifloxacin | Drug |
|
| BI 201335 high dose | Drug |
|
| The time-matched changes versus placebo in QTcI at any point in time between 2 h and 24 h after dosing | Pre dose and 2 to 24 hours post dosing |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |