Influence of Pramipexole on the QT Interval of the ECG in Healthy Male and Female Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Pramipexole Placebo; Drug: Moxifloxacin Placebo; Drug: Moxifloxacin; Drug: Pramipexole immediate-release (IR) tablets; Drug: Pramipexole extended-release (ER) tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT02262546

248.545

Details and patient eligibility

About

The objective of the study is to assess that pramipexole does not prolong the QT interval more than placebo

Enrollment: 60 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 4 patient groups, including a placebo group

Pramipexole

Experimental group

Treatment:

Drug: Pramipexole immediate-release (IR) tablets

Drug: Pramipexole extended-release (ER) tablets

Moxifloxacin

Active Comparator group

Treatment:

Drug: Moxifloxacin

Pramipexole Placebo

Placebo Comparator group

Treatment:

Drug: Pramipexole Placebo

Moxifloxacin Placebo

Placebo Comparator group

Treatment:

Drug: Moxifloxacin Placebo