Healthy
Conditions
Brief summary
The objective of the study is to assess that pramipexole does not prolong the QT interval more than placebo
Interventions
DRUGPramipexole extended-release (ER) tablets
DRUGPramipexole immediate-release (IR) tablets
DRUGMoxifloxacin
DRUGPramipexole Placebo
DRUGMoxifloxacin Placebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* All participants in the study need to be healthy males or females 21 to 50 years of age * Body mass index (BMI) ranging from 18.5 to 29.9 kg/m2 * 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 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 ten 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 pramipexole, moxifloxacin and/or related drugs of these classes * Supine blood pressure at screening of systolic \< 100 mmHg and diastolic \< 60 mmHg * Heart rate at screening of \> 80 beats per minute (bpm) or \< 40 bpm * Any screening ECG value outside of the reference range of clinical relevance including, but not limited to Pulse Rate interval \> 220 ms, QRS interval \> 115 ms, QTcB or QTcF \> 450 ms, or QT (uncorrected) \> 470 ms * Subjects involved in passenger transport or operation of dangerous machines For Female Subjects: * Pregnancy * Positive pregnancy test * No adequate contraception (adequate contraception: e.g. sterilization, intrauterine device, oral contraceptives) * Inability to maintain this adequate contraception during the whole study period * Lactation period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean of the individually heart rate corrected QT interval (QTcI) values | 1 to 4 hours after dosing on day 21 |
Secondary
| Measure | Time frame |
|---|---|
| Mean of the QTcI values | 1 to 4 hours after dosing at day 12 |
| QTcI at any point in time | between 1 and 7 hours after dosing at day 12 and day 21 |
Outcome results
None listed