HealthyPhase 1NCT02261103
Bioavailability of Increasing Pramipexole Doses of Oral Extended Release (ER) Tablets in Healthy Male Volunteers
A Phase 1 study testing Pramipexole ER tablets, Pramipexole IR tablets and Standard high-fat breakfast in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objectives of the studies are: To demonstrate similar total exposure between pramipexole ER fasted and pramipexole ER fed after multiple administration of the highest daily dose of 4.5 mg q.d. Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pramipexole ER tablets, Pramipexole IR tablets and Standard high-fat breakfast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Jul 2006
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participants in the study should be healthy males
- Age range from 21 to 50 years
- Body mass index (BMI) be within 18.5 to 29.9 kg/m2
- In accordance with Good Clinical Practice and the local legislation all volunteers will have given their written informed consent prior to admission to the study
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 18Show fewer
- Intake of drugs with a long half-life (> 24:00 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 (≤ one month prior to administration or during the trial)
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking on in-house trial days
- Alcohol abuse (> 40 g/day)
- Drug abuse
- Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
- Any laboratory value outside the clinically accepted reference range
- Excessive physical activities within the last week before the trial or during the trial
- Hypersensitivity to pramipexole, or other dopamine agonists
- Supine blood pressure at screening of systolic < 110 mmHg and diastolic < 60 mmHg
About this study
Official title: A Multiple Dose Study With Increasing Pramipexole Doses (0.375 mg to 4.5 mg q.d.) of Oral Extended Release (ER) Tablets With a Three-way Cross Comparison of 4.5 mg Pramipexole ER q.d. Fasted Versus 4.5 mg Pramipexole ER q.d. Fed Versus 1.5 mg Pramipexole Immediate Release Tablets t.i.d. Fasted in Healthy Male Volunteers
The objectives of the studies are:
- To demonstrate similar total exposure between pramipexole ER fasted and pramipexole ER fed after multiple administration of the highest daily dose of 4.5 mg q.d. and to reveal any food effect leading to uncontrolled release
- To investigate the relative bioavailability of the ER-formulation of pramipexole in comparison to the IR-formulation at the highest daily dose of 4.5 mg after multiple dosing
- To demonstrate dose proportionality between the dose strengths of the pramipexole ER formulation of 0.375, 0.75, 1.5, 3.0, and 4.5 mg after multiple daily (q.d.) dosing
- Conditions
- Healthy
- Being tested
- Pramipexole ER tablets, Pramipexole IR tablets, Placebo matching Pramipexole ER tablets, Placebo matching Pramipexole IR tablets, Standard high-fat breakfast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pramipexole ER tabletsDrug
Pramipexole IR tabletsDrug
Placebo matching Pramipexole ER tabletsDrug
Placebo matching Pramipexole IR tabletsDrug
Standard high-fat breakfastOther
| Study group | Role | What they receive |
|---|---|---|
| Pramipexole IR, fasted | Active comparator | Pramipexole immediate release (IR) tablets Receives: Drug: Pramipexole IR tablets; Drug: Placebo matching Pramipexole ER tablets |
| Pramipexole ER, fasted | Experimental | Pramipexole extended release (ER) tablets Receives: Drug: Pramipexole ER tablets; Drug: Placebo matching Pramipexole IR tablets |
| Pramipexole ER, fed | Experimental | Pramipexole extended release tablets with a high-fat meal 30 min before drug administration Receives: Drug: Pramipexole ER tablets; Other: Standard high-fat breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ=0-24h (AUC0-24,ss) for ER
Measured: up to 23 hours after drug application on day 5
AUC0-24,ss for IR
Measured: up to 23 hours after drug application on day 5
Maximum measured concentration of the analyte in plasma at steady state (Cmax)
Measured: up to 23 hours after drug application on day 5
Area under the concentration-time curve of the analyte in plasma over the time interval 0 to 4h at steady state (AUC0-4,ss) for ER
Measured: up to 4 hours after drug application
Secondary outcomes (17)
Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Measured: up to 23 hours after drug application on day 5
Peak-Trough Fluctuation (PTF)
Measured: up to 23 hours after drug application on day 5
Time from last dosing to the maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (tmax,ss)
Measured: up to 23 hours after drug application on day 5
Area under the concentration-time curve of the analyte in plasma over the time interval 0 to 8 h at steady state (AUC0-8,ss)
Measured: up to 8 hours after drug application
Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss)
Measured: predose on days 1 to 5
Average concentration of the analyte in plasma at steady state (Cavg)
Measured: up to 23 hours after drug application on day 5
Terminal half-life of the analyte in plasma at steady state (t1/2,ss)
Measured: up to 23 hours after drug application on day 5
Mean residence time of the analyte in the body at steady state after p.o. administration (MRTpo,ss)
Measured: up to 23 hours after drug application on day 5
Apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration (CL/F,ss)
Measured: up to 23 hours after drug application on day 5
Renal clearance of the analyte at steady state determined over the dosing interval τ (CLR,ss)
Measured: up to 23 hours after drug application on day 5
Apparent volume of distribution during the terminal phase λz at steady state following extravascular administration (Vz/F,ss)
Measured: up to 23 hours after drug application on day 5
Amount of analyte that is eliminated in urine at steady state from the time point 0 to time point 24 (Ae0-24,ss)
Measured: up to 23 hours after drug application on day 5
Amount of analyte that is eliminated in urine at steady state from the time point 0 to time point 8 (Ae0-8,ss) for IR
Measured: up to 8 hours after drug application on day 5
Number of subjects with adverse events
Measured: up to 7 days after last drug administration
Number of subjects with clinically relevant changes in vital signs
Measured: up to 7 days after last drug administration
Number of subjects with clinically relevant changes in laboratory parameters
Measured: up to 7 days after last drug administration
Assessment of global tolerability by investigator on a 4-point scale
Measured: day 5 of each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startApr 2006
- Primary completionJul 2006
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
- 39 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
- NCT02261103
- Sponsor's protocol ID
- 248.530
- Status last verified
- Oct 2014
- First submitted
- 9 Oct 2014
- Last updated
- 10 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Study With Increasing Pramipexole Doses (0.375 mg to 4.5 mg q.d.) of Oral Extended Release (ER) Tablets With a Three-way Cross Comparison of 4.5 mg Pramipexole ER q.d. Fasted Versus 4.5 mg Pramipexole ER q.d. Fed Versus 1.5 mg Pramipexole Immediate Release Tablets t.i.d. Fasted in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02261103
- Acronym / sponsor ID
- 248.530
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Jul 2006 (actual)
- First posted
- 10 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 objectives of the studies are:
- To demonstrate similar total exposure between pramipexole ER fasted and pramipexole ER fed after multiple administration of the highest daily dose of 4.5 mg q.d. and to reveal any food effect leading to uncontrolled release
- To investigate the relative bioavailability of the ER-formulation of pramipexole in comparison to the IR-formulation at the highest daily dose of 4.5 mg after multiple dosing
- To demonstrate dose proportionality between the dose strengths of the pramipexole ER formulation of 0.375, 0.75, 1.5, 3.0, and 4.5 mg after multiple daily (q.d.) dosing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pramipexole IR, fasted | Active comparator | Drug: Pramipexole IR tablets, Drug: Placebo matching Pramipexole ER tabletsPramipexole immediate release (IR) tablets |
| Pramipexole ER, fasted | Experimental | Drug: Pramipexole ER tablets, Drug: Placebo matching Pramipexole IR tabletsPramipexole extended release (ER) tablets |
| Pramipexole ER, fed | Experimental | Drug: Pramipexole ER tablets, Other: Standard high-fat breakfastPramipexole extended release tablets with a high-fat meal 30 min before drug administration |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All participants in the study should be healthy males
- Age range from 21 to 50 years
- Body mass index (BMI) be within 18.5 to 29.9 kg/m2
- In accordance with Good Clinical Practice and the local legislation all volunteers will have given their written informed consent prior to admission to the study
Key exclusion criteria (18 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 ER tablets | Drug | Pramipexole ER, fasted, Pramipexole ER, fed |
| Pramipexole IR tablets | Drug | Pramipexole IR, fasted |
| Placebo matching Pramipexole ER tablets | Drug | Pramipexole IR, fasted |
| Placebo matching Pramipexole IR tablets | Drug | Pramipexole ER, fasted |
| Standard high-fat breakfast | Other | Pramipexole ER, fed |
Primary outcome
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ=0-24h (AUC0-24,ss) for ER
Time frame: up to 23 hours after drug application on day 5
AUC0-24,ss for IR
Time frame: up to 23 hours after drug application on day 5
Maximum measured concentration of the analyte in plasma at steady state (Cmax)
Time frame: up to 23 hours after drug application on day 5
Area under the concentration-time curve of the analyte in plasma over the time interval 0 to 4h at steady state (AUC0-4,ss) for ER
Time frame: up to 4 hours after drug application
17 secondary outcomes
Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Time frame: up to 23 hours after drug application on day 5
Peak-Trough Fluctuation (PTF)
Time frame: up to 23 hours after drug application on day 5
Time from last dosing to the maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (tmax,ss)
Time frame: up to 23 hours after drug application on day 5
Area under the concentration-time curve of the analyte in plasma over the time interval 0 to 8 h at steady state (AUC0-8,ss)
Time frame: up to 8 hours after drug application
Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss)
Time frame: predose on days 1 to 5
Average concentration of the analyte in plasma at steady state (Cavg)
Time frame: up to 23 hours after drug application on day 5
Terminal half-life of the analyte in plasma at steady state (t1/2,ss)
Time frame: up to 23 hours after drug application on day 5
Mean residence time of the analyte in the body at steady state after p.o. administration (MRTpo,ss)
Time frame: up to 23 hours after drug application on day 5
Apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration (CL/F,ss)
Time frame: up to 23 hours after drug application on day 5
Renal clearance of the analyte at steady state determined over the dosing interval τ (CLR,ss)
Time frame: up to 23 hours after drug application on day 5
Apparent volume of distribution during the terminal phase λz at steady state following extravascular administration (Vz/F,ss)
Time frame: up to 23 hours after drug application on day 5
Amount of analyte that is eliminated in urine at steady state from the time point 0 to time point 24 (Ae0-24,ss)
Time frame: up to 23 hours after drug application on day 5
Amount of analyte that is eliminated in urine at steady state from the time point 0 to time point 8 (Ae0-8,ss) for IR
Time frame: up to 8 hours after drug application on day 5
Number of subjects with adverse events
Time frame: up to 7 days after last drug administration
Number of subjects with clinically relevant changes in vital signs
Time frame: up to 7 days after last drug administration
Number of subjects with clinically relevant changes in laboratory parameters
Time frame: up to 7 days after last drug administration
Assessment of global tolerability by investigator on a 4-point scale
Time frame: day 5 of each visit
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 10 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 ER tablets, Pramipexole IR tablets and Standard high-fat breakfast 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 4 inclusion and 18 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 10 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. 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?
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ=0-24h (AUC0-24,ss) for ER (time frame: up to 23 hours after drug application on day 5). The study lists 4 primary outcomes in all. 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 10 Oct 2014.