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

NCT02262546 | Completed Phase 1

• 1 other identifier: 248.545
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Mean of the individually heart rate corrected QT interval (QTcI) values

  1 to 4 hours after dosing on day 21

Secondary Outcomes (2)

• 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

Study Arms (4)

Pramipexole

EXPERIMENTAL

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

Moxifloxacin

ACTIVE COMPARATOR

Drug: Moxifloxacin

Pramipexole Placebo

PLACEBO COMPARATOR

Drug: Pramipexole Placebo

Moxifloxacin Placebo

PLACEBO COMPARATOR

Drug: Moxifloxacin Placebo

Interventions

Pramipexole extended-release (ER) tablets DRUG

Pramipexole

Pramipexole immediate-release (IR) tablets DRUG

Pramipexole

Moxifloxacin DRUG

Moxifloxacin

Pramipexole Placebo DRUG

Pramipexole Placebo

Moxifloxacin Placebo DRUG

Moxifloxacin Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Tablets; Moxifloxacin

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 13, 2014
• Study Start: May 1, 2007
• Primary Completion: October 1, 2007
• Last Updated: October 13, 2014

Record last verified: 2014-10