HealthyPhase 1NCT02262546
Influence of Pramipexole on the QT Interval of the ECG in Healthy Male and Female Volunteers
A Phase 1 study testing Pramipexole extended-release (ER) tablets, Pramipexole immediate-release (IR) tablets and Moxifloxacin in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objective of the study is to assess that pramipexole does not prolong the QT interval more than placebo Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pramipexole extended-release (ER) tablets, Pramipexole immediate-release (IR) tablets and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Oct 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 27Show fewer
- 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
About this study
Official title: A Double-blind, Randomised, Placebo Controlled Study With Two Sequential Two-way Cross-over Parts to Demonstrate That the Influence of Pramipexole up to 4.5 mg Daily on the QT Interval of the ECG in Healthy Male and Female Volunteers is Comparable With Placebo, With a Positive Control (Two-way Cross-over Moxifloxacin Versus Placebo)
The objective of the study is to assess that pramipexole does not prolong the QT interval more than placebo
- Conditions
- Healthy
- Being tested
- Pramipexole extended-release (ER) tablets, Pramipexole immediate-release (IR) tablets, Moxifloxacin, Pramipexole Placebo, Moxifloxacin Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pramipexole extended-release (ER) tabletsDrug
Pramipexole immediate-release (IR) tabletsDrug
MoxifloxacinDrug
Pramipexole PlaceboDrug
Moxifloxacin PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Pramipexole | Experimental | Not described Receives: Drug: Pramipexole extended-release (ER) tablets; Drug: Pramipexole immediate-release (IR) tablets |
| Moxifloxacin | Active comparator | Not described Receives: Drug: Moxifloxacin |
| Pramipexole Placebo | Placebo comparator | Not described Receives: Drug: Pramipexole Placebo |
| Moxifloxacin Placebo | Placebo comparator | Not described Receives: Drug: Moxifloxacin Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of the individually heart rate corrected QT interval (QTcI) values
Measured: 1 to 4 hours after dosing on day 21
Secondary outcomes (2)
Mean of the QTcI values
Measured: 1 to 4 hours after dosing at day 12
QTcI at any point in time
Measured: between 1 and 7 hours after dosing at day 12 and day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startMay 2007
- Primary completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262546
- Sponsor's protocol ID
- 248.545
- Status last verified
- Oct 2014
- First submitted
- 9 Oct 2014
- Last updated
- 13 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Placebo Controlled Study With Two Sequential Two-way Cross-over Parts to Demonstrate That the Influence of Pramipexole up to 4.5 mg Daily on the QT Interval of the ECG in Healthy Male and Female Volunteers is Comparable With Placebo, With a Positive Control (Two-way Cross-over Moxifloxacin Versus Placebo)
- ClinicalTrials.gov ID
- NCT02262546
- Acronym / sponsor ID
- 248.545
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Oct 2007 (actual)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to assess that pramipexole does not prolong the QT interval more than placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Mean of the individually heart rate corrected QT interval (QTcI) values
Time frame: 1 to 4 hours after dosing on day 21
2 secondary outcomes
Mean of the QTcI values
Time frame: 1 to 4 hours after dosing at day 12
QTcI at any point in time
Time frame: between 1 and 7 hours after dosing at day 12 and day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pramipexole extended-release (ER) tablets, Pramipexole immediate-release (IR) tablets and Moxifloxacin in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean of the individually heart rate corrected QT interval (QTcI) values (time frame: 1 to 4 hours after dosing on day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2014.