HealthyPhase 1NCT02256878
Study to Evaluate the Effect Single and Multiple Oral Doses of BIRT 2584 XX Tablets on the Pharmacokinetic Parameters of Amitriptyline and Nortriptyline in Healthy Male and Female Subjects
A Phase 1 study testing BIRT 2584 XX and Amitriptyline in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objective of the study was evaluate that there is no clinically relevant interaction between amitriptyline (or its metabolite nortriptyline) and BIRT 2584 XX (or its metabolite BI 610100) when BIRT 2584 XX is administered as a tablet formulation to near steady state in an estimated high therapeutic dose. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIRT 2584 XX and Amitriptyline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Aug 2004to Nov 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female or male volunteers as determined by the results of screening based upon a complete medical history, including physical examination, measurement of vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead ECG, and clinical laboratory tests
- Age ≥ 18 and ≤ 55 years
- BMI ≥ 18.5 and ≤ 29.9 kg/m2 (body mass index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
Who cannot join
- Any finding of the medical examination (including BP, PR, and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hematologic, oncologic or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the Central Nervous System (CNS) (such as epilepsy) or psychiatric disorders or neurological disorders
- Relevant history of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
Show all 23Show fewer
- 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 h) within 1 month prior to administration of the study drug or during the trial
- Use of any drugs which might influence the results of the trial within 10 days prior to study drug administration or expected during the trial
- Participation in another trial with an investigational drug within 2 months prior to administration or expected during the trial
- Smoker (>10 cigarettes or >3 cigars or >3 pipes/day); inability to abstain from smoking within 5 days before first drug administration until completion of the trial
- Alcohol abuse (>60 g/day)
- Drug abuse
- Blood donation or loss >400 mL, within 1 month prior to study drug administration or expected during the trial
- Clinically relevant laboratory abnormalities
- For male subjects:
- Male subjects whose sexual partners are currently not using an adequate method of contraception that would prospectively be maintained during the study, are to be excluded
- Male subjects who are not willing to use condoms are to be excluded
- For female subjects:
- Pregnancy
- Positive pregnancy test
- No highly safe method of contraception in women of childbearing potential (in this context, only sterilization or male partner sterilization is considered a highly safe method of contraception). Hormonal contraceptives are not considered adequate due to possible drug interaction with BIRT 2584 XX
- Lactation period
About this study
Official title: A Study to Evaluate the Effect of a Single Oral Dose and Multiple Oral Doses of 500 mg of BIRT 2584 XX Tablets on the Pharmacokinetic Parameters of Amitriptyline and Nortriptyline in Healthy Male and Female Subjects
The objective of the study was evaluate that there is no clinically relevant interaction between amitriptyline (or its metabolite nortriptyline) and BIRT 2584 XX (or its metabolite BI 610100) when BIRT 2584 XX is administered as a tablet formulation to near steady state in an estimated high therapeutic dose. Pharmacokinetics (PK) of amitriptyline and nortriptyline were measured before dosing of BIRT 2584 XX, after the first dose of BIRT 2584 XX, and after repeated doses of BIRT 2584 XX near steady state
- Conditions
- Healthy
- Being tested
- BIRT 2584 XX, Amitriptyline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIRT 2584 XXDrug
AmitriptylineDrug
Also called Saroten®
| Study group | Role | What they receive |
|---|---|---|
| BIRT 2584 XX + Amitriptyline | Experimental | BIRT 2584 XX:
Days 1 and 2: twice daily (bid) Days 3 to 21: once daily (qd)
Amitriptyline:
Single dose on day -8, day 1, and day 15 Receives: Drug: BIRT 2584 XX; Drug: Amitriptyline |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞ of amitriptyline (area under the concentration-time curve of amitriptyline in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 15 days
AUC0-∞ ratio of amitriptyline/nortriptyline
Measured: up to 15 days
Secondary outcomes (16)
AUC0-∞ of amitriptyline (area under the concentration-time curve of amitriptyline in plasma over the time interval from 0 extrapolated to infinity)
1 hour after BIRT 2584 XX
Measured: Day 1
Cmax of amitriptyline (maximum concentration of amitriptyline in plasma)
Measured: up to 15 days
AUC0-∞ of nortriptyline (area under the concentration-time curve of nortriptyline in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 15 days
Cmax of nortriptyline (maximum concentration of nortriptyline in plasma)
Measured: up to 15 days
AUC0-∞ ratio of amitriptyline/nortriptyline
1 hour after BIRT 2584 XX
Measured: Day 1
AUC0-tz (area under the concentration-time curve of the analytes in plasma over the time interval from 0 to the time of the last quantifiable data point)
Measured: up to 15 days
tmax (time from dosing to the maximum concentration of the analytes in plasma)
Measured: up to 15 days
λz (terminal rate constant of the analytes in plasma)
Measured: up to 15 days
t1/2 (terminal half-life of the analytes in plasma)
Measured: up to 15 days
MRTpo (mean residence time of the analytes in the body after po administration)
Measured: up to 15 days
CL/F (apparent clearance of the analytes in the plasma after extravascular administration)
Measured: up to 15 days
Vz/F (apparent volume of distribution during the terminal phase following an extravascular dose)
Measured: up to 15 days
Pre-dose levels of BIRT 2584 XX and BI 610100
Measured: up to 15 days
Number of subjects with adverse events
Measured: up to 57 days
Number of subjects with abnormal changes in laboratory parameters
Measured: up to 28 days
Assessment of tolerability by investigator on a 4-point scale
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study startAug 2004
- Primary completionNov 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT02256878
- Sponsor's protocol ID
- 1206.12
- Status last verified
- Oct 2014
- First submitted
- 2 Oct 2014
- Last updated
- 6 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effect of a Single Oral Dose and Multiple Oral Doses of 500 mg of BIRT 2584 XX Tablets on the Pharmacokinetic Parameters of Amitriptyline and Nortriptyline in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT02256878
- Acronym / sponsor ID
- 1206.12
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Nov 2006 (actual)
- First posted
- 6 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 was evaluate that there is no clinically relevant interaction between amitriptyline (or its metabolite nortriptyline) and BIRT 2584 XX (or its metabolite BI 610100) when BIRT 2584 XX is administered as a tablet formulation to near steady state in an estimated high therapeutic dose. Pharmacokinetics (PK) of amitriptyline and nortriptyline were measured before dosing of BIRT 2584 XX, after the first dose of BIRT 2584 XX, and after repeated doses of BIRT 2584 XX near steady state
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIRT 2584 XX + Amitriptyline | Experimental | Drug: BIRT 2584 XX, Drug: AmitriptylineBIRT 2584 XX: Days 1 and 2: twice daily (bid) Days 3 to 21: once daily (qd) Amitriptyline: Single dose on day -8, day 1, and day 15 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy female or male volunteers as determined by the results of screening based upon a complete medical history, including physical examination, measurement of vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead ECG, and clinical laboratory tests
- Age ≥ 18 and ≤ 55 years
- BMI ≥ 18.5 and ≤ 29.9 kg/m2 (body mass index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
Key exclusion criteria (23 listed)
- Any finding of the medical examination (including BP, PR, and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hematologic, oncologic or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the Central Nervous System (CNS) (such as epilepsy) or psychiatric disorders or neurological disorders
- Relevant history of orthostatic hypotension, fainting spells or blackouts
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 |
|---|---|---|
| BIRT 2584 XX | Drug | BIRT 2584 XX + Amitriptyline |
| AmitriptylineAlso: Saroten® | Drug | BIRT 2584 XX + Amitriptyline |
Primary outcome
AUC0-∞ of amitriptyline (area under the concentration-time curve of amitriptyline in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 15 days
AUC0-∞ ratio of amitriptyline/nortriptyline
Time frame: up to 15 days
16 secondary outcomes
AUC0-∞ of amitriptyline (area under the concentration-time curve of amitriptyline in plasma over the time interval from 0 extrapolated to infinity)
Time frame: Day 1
Cmax of amitriptyline (maximum concentration of amitriptyline in plasma)
Time frame: up to 15 days
AUC0-∞ of nortriptyline (area under the concentration-time curve of nortriptyline in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 15 days
Cmax of nortriptyline (maximum concentration of nortriptyline in plasma)
Time frame: up to 15 days
AUC0-∞ ratio of amitriptyline/nortriptyline
Time frame: Day 1
AUC0-tz (area under the concentration-time curve of the analytes in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: up to 15 days
tmax (time from dosing to the maximum concentration of the analytes in plasma)
Time frame: up to 15 days
λz (terminal rate constant of the analytes in plasma)
Time frame: up to 15 days
t1/2 (terminal half-life of the analytes in plasma)
Time frame: up to 15 days
MRTpo (mean residence time of the analytes in the body after po administration)
Time frame: up to 15 days
CL/F (apparent clearance of the analytes in the plasma after extravascular administration)
Time frame: up to 15 days
Vz/F (apparent volume of distribution during the terminal phase following an extravascular dose)
Time frame: up to 15 days
Pre-dose levels of BIRT 2584 XX and BI 610100
Time frame: up to 15 days
Number of subjects with adverse events
Time frame: up to 57 days
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to 28 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: Day 28
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 6 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 BIRT 2584 XX and Amitriptyline 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 23 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 6 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?
AUC0-∞ of amitriptyline (area under the concentration-time curve of amitriptyline in plasma over the time interval from 0 extrapolated to infinity) (time frame: up to 15 days). The study lists 2 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 6 Oct 2014.