HealthyPhase 1NCT02305901
The Effect of Multiple Doses of BI 187004 on the Single-dose Pharmacokinetics of Repaglinide and Bupropion in Healthy Male Volunteers
A Phase 1 study testing repaglinide, BI 187004 tablet and bupropion extended release tablet in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
To assess the influence of BI 187004 on pharmacokinetics of CYP2C8 and CYP2B6 probe drugs repaglinide and bupropion as a means of predicting drug-drug interactions. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- repaglinide, BI 187004 tablet and bupropion extended release tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2014to Mar 2015
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
- Age of 18 to 55 years (incl.)
- Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Who cannot join
- Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease judged as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
- Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- Further exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Multiple Doses of BI 187004 on the Single-dose Pharmacokinetics of Repaglinide and Bupropion Following Oral Administration in Healthy Male Subjects (an Open-label, One-sequence Trial)
To assess the influence of BI 187004 on pharmacokinetics of CYP2C8 and CYP2B6 probe drugs repaglinide and bupropion as a means of predicting drug-drug interactions.
- Conditions
- Healthy
- Being tested
- repaglinide, BI 187004 tablet, bupropion extended release tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repaglinideDrug
single dose on day 1 of visits 2 and 3
BI 187004 tabletDrug
multiple doses on days 8-13 of visit 2 and days 1-7 of visit 3
bupropion extended release tabletDrug
single dose on day 3 of visits 2 and 3
| Study group | Role | What they receive |
|---|---|---|
| Repaglinide + Bupropion + BI 187004 | Experimental | repaglinide tablets and bupropion tablets with and without concomitant administration of BI 187004 Receives: Drug: repaglinide; Drug: BI 187004 tablet; Drug: bupropion extended release tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of repaglinide in plasma over the time interval from 0 to the last quantifiable data point
Measured: up to 48 h post dose
Maximum measured concentration of repaglinide in plasma
Measured: up to 48 h post dose
Area under the concentration-time curve of total bupropion in plasma over the time interval from 0 to the last quantifiable data point
Measured: up to 119 h post dose
Area under the concentration-time curve of S-bupropion in plasma over the time interval from 0 to the last quantifiable data point
Measured: up to 119 h post dose
Maximum measured concentration of total bupropion in plasma
Measured: up to 119 h post dose
Maximum measured concentration of S-bupropion in plasma
Measured: up to 119 h post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2015
- Study completionMar 2015
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305901
- Sponsor's protocol ID
- 1307.20
- Other IDs
- 2013-005030-38
- Status last verified
- May 2015
- First submitted
- 1 Dec 2014
- Last updated
- 12 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Multiple Doses of BI 187004 on the Single-dose Pharmacokinetics of Repaglinide and Bupropion Following Oral Administration in Healthy Male Subjects (an Open-label, One-sequence Trial)
- ClinicalTrials.gov ID
- NCT02305901
- Acronym / sponsor ID
- 1307.20
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 3 Dec 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.
To assess the influence of BI 187004 on pharmacokinetics of CYP2C8 and CYP2B6 probe drugs repaglinide and bupropion as a means of predicting drug-drug interactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Repaglinide + Bupropion + BI 187004 | Experimental | Drug: repaglinide, Drug: BI 187004 tablet, Drug: bupropion extended release tabletrepaglinide tablets and bupropion tablets with and without concomitant administration of BI 187004 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
- Age of 18 to 55 years (incl.)
- Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Key exclusion criteria (8 listed)
- Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease judged as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
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 |
|---|---|---|
| repaglinidesingle dose on day 1 of visits 2 and 3 | Drug | Repaglinide + Bupropion + BI 187004 |
| BI 187004 tabletmultiple doses on days 8-13 of visit 2 and days 1-7 of visit 3 | Drug | Repaglinide + Bupropion + BI 187004 |
| bupropion extended release tabletsingle dose on day 3 of visits 2 and 3 | Drug | Repaglinide + Bupropion + BI 187004 |
Primary outcome
Area under the concentration-time curve of repaglinide in plasma over the time interval from 0 to the last quantifiable data point
Time frame: up to 48 h post dose
Maximum measured concentration of repaglinide in plasma
Time frame: up to 48 h post dose
Area under the concentration-time curve of total bupropion in plasma over the time interval from 0 to the last quantifiable data point
Time frame: up to 119 h post dose
Area under the concentration-time curve of S-bupropion in plasma over the time interval from 0 to the last quantifiable data point
Time frame: up to 119 h post dose
Maximum measured concentration of total bupropion in plasma
Time frame: up to 119 h post dose
Maximum measured concentration of S-bupropion in plasma
Time frame: up to 119 h post dose
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 12 May 2015.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing repaglinide, BI 187004 tablet and bupropion extended release tablet in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
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 8 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 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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 repaglinide in plasma over the time interval from 0 to the last quantifiable data point (time frame: up to 48 h post dose). The study lists 6 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 12 May 2015.