Influence of Pramipexole on the QT Interval of the ECG in Healthy Male and Female Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT02262546
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of the study is to assess that pramipexole does not prolong the QT interval more than placebo
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Pramipexole Pramipexole immediate-release (IR) tablets - Pramipexole Placebo Pramipexole Placebo - Pramipexole Pramipexole extended-release (ER) tablets - Moxifloxacin Moxifloxacin - Moxifloxacin Placebo Moxifloxacin Placebo -
- Primary Outcome Measures
Name Time Method Mean of the individually heart rate corrected QT interval (QTcI) values 1 to 4 hours after dosing on day 21
- Secondary Outcome Measures
Name Time Method QTcI at any point in time between 1 and 7 hours after dosing at day 12 and day 21 Mean of the QTcI values 1 to 4 hours after dosing at day 12