HealthyPhase 1NCT02211950
Relative Bioavailability of BI 44847 in Different Ethnic Groups and Evaluation of Effect of Diet and Acarbose Coadministration on Bioavailability Following Oral Administration of 200 mg BI 44847 in Healthy Male Volunteers
A Phase 1 study testing BI 44847, Acarbose and Japanese diet in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objectives were to investigate the relative bioavailability of BI 44847 in different racial groups (white, Asian, and African subjects) and to investigate the effect of different types of diet and acarbose coadministration on the bioavailability of BI 44847 in white subjects. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 44847, Acarbose and Japanese diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Dec 2008
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects determined by results of screening
- Age 18 - 40 years
- Body Mass Index 18 - 25 kg/m2, at least 45 kg
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Who cannot join
- Significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders as judged by the investigator
- Relevant gastrointestinal tract surgery
- Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or relevant neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts; systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, pulse rate out of 45 to 90 beats per minute
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergies) that are deemed relevant to the trial as judged by the investigator
Show all 19Show fewer
- Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use within 10 days prior to administration or during the trial of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation
- Participation in another trial with an investigational drug within 2 months after a multiple dose study or within 1 month after a single dose study
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
- Inability to refrain from smoking when confined to the study site on trial days
- Alcohol abuse (more than 60 g/day in males, more than 40 g/day in females)
- Drug abuse, in the investigator's judgment upon review of the patient's history and urine screening for abused substances
- Veins unsuited for iv puncture on either arm (e.g. veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture)
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within 48 hours prior to trial or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance according to the assessment of the investigator
- Inability to comply with dietary regimen of study centre
- Subjects not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
About this study
Official title: Evaluation of Relative Bioavailability of BI 44847 in Different Ethnic Groups (Subjects of White, Asian, and African Origin), and Evaluation of Effect of Diet and Acarbose Coadministration on Bioavailability Following Oral Administration of 200 mg BI 44847 in Healthy Male Volunteers. An Open-label, Single-dose, Parallel Group, Phase 1 Study (Group 1 With Additional Crossover Aspects)
The objectives were to investigate the relative bioavailability of BI 44847 in different racial groups (white, Asian, and African subjects) and to investigate the effect of different types of diet and acarbose coadministration on the bioavailability of BI 44847 in white subjects.
- Conditions
- Healthy
- Being tested
- BI 44847, Acarbose, Japanese diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 44847Drug
AcarboseDrug
Also called Glucobay
Japanese dietOther
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | single dose BI 44847 administered to white subjects Receives: Drug: BI 44847 |
| Treatment B | Experimental | 100 mg acarbose for 2 days, on the second day a single dose BI 44847 administered to white subjects Receives: Drug: BI 44847; Drug: Acarbose |
| Treatment C | Experimental | single dose BI 44847 after a Japanese diet of 6 days administered to white subjects Receives: Drug: BI 44847; Other: Japanese diet |
| Treatment D | Experimental | single dose BI 44847 administered to asian subjects Receives: Drug: BI 44847 |
| Treatment E | Experimental | single dose BI 44847 administered to african subjects Receives: Drug: BI 44847 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞ (area under the concentration time curve of the analyte in plasma in plasma over the time interval from 0 to infinity)
Measured: up to 48 hours after drug administration
AUC0-48 (area under the concentration time curve of the analyte in plasma over the time interval from 0 to 48 h)
Measured: up to 48 hours after drug administration
AUC0-12 (area under the concentration time curve of the analyte in plasma over the time interval from 0 to 12 h)
Measured: up to 48 hours after drug administration
Cmax (maximum concentration of the analyte in plasma)
Measured: up to 48 hours after drug administration
Secondary outcomes (16)
tmax (time from dosing to maximum concentration of the analyte in plasma)
Measured: up to 48 hours after drug administration
λz (terminal rate constant in plasma after single dose
Measured: up to 48 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma after single dose)
Measured: up to 48 hours after drug administration
MRTpo (mean residence time of the analyte in the body after single dose)
Measured: up to 48 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration after single dose)
Measured: up to 48 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz after single dose following extravascular administration)
Measured: up to 48 hours after drug administration
AUCt1-t2 (area under the concentration time curve of analyte in plasma over the time interval t1 to t2)
Measured: up to 24 hours after drug administration
Aet1-t2 (amount of drug that is eliminated in urine from the time point t1 to time point t2)
Measured: up to 24 hours after drug administration
fet1-t2 (fraction of drug eliminated in urine from time point t1 to time point t2)
Measured: up to 24 hours after drug administration
CLR,t1-t2 (renal clearance of the drug from the time point t1 until the time point t2)
Measured: up to 24 hours after drug administration
Amount of glucose excreted in urine
Measured: up to 24 hours after drug administration
Number of patients with adverse events
Measured: up to 48 hours after last administration of study drug
Number of patients with clinically relevant changes in laboratory tests
Measured: up to 48 hours after last administration of study drug
Number of patients with clinically relevant changes in Electrocardiogram (ECG)
Measured: up to 48 hours after last administration of study drug
Number of patients with clinically relevant changes in vital signs
Measured: up to 48 hours after last administration of study drug
Assessment of global tolerability by investigator on a 4-point scale
Measured: 48 hours after last administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startOct 2008
- Primary completionDec 2008
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 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
- NCT02211950
- Sponsor's protocol ID
- 1224.22
- Status last verified
- Aug 2014
- First submitted
- 7 Aug 2014
- Last updated
- 8 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Relative Bioavailability of BI 44847 in Different Ethnic Groups (Subjects of White, Asian, and African Origin), and Evaluation of Effect of Diet and Acarbose Coadministration on Bioavailability Following Oral Administration of 200 mg BI 44847 in Healthy Male Volunteers. An Open-label, Single-dose, Parallel Group, Phase 1 Study (Group 1 With Additional Crossover Aspects)
- ClinicalTrials.gov ID
- NCT02211950
- Acronym / sponsor ID
- 1224.22
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Dec 2008 (actual)
- First posted
- 8 Aug 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 were to investigate the relative bioavailability of BI 44847 in different racial groups (white, Asian, and African subjects) and to investigate the effect of different types of diet and acarbose coadministration on the bioavailability of BI 44847 in white subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: BI 44847single dose BI 44847 administered to white subjects |
| Treatment B | Experimental | Drug: BI 44847, Drug: Acarbose100 mg acarbose for 2 days, on the second day a single dose BI 44847 administered to white subjects |
| Treatment C | Experimental | Drug: BI 44847, Other: Japanese dietsingle dose BI 44847 after a Japanese diet of 6 days administered to white subjects |
| Treatment D | Experimental | Drug: BI 44847single dose BI 44847 administered to asian subjects |
| Treatment E | Experimental | Drug: BI 44847single dose BI 44847 administered to african subjects |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects determined by results of screening
- Age 18 - 40 years
- Body Mass Index 18 - 25 kg/m2, at least 45 kg
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Key exclusion criteria (19 listed)
- Significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders as judged by the investigator
- Relevant gastrointestinal tract surgery
- Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or relevant neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts; systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, pulse rate out of 45 to 90 beats per minute
- 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 |
|---|---|---|
| BI 44847 | Drug | Treatment A, Treatment B, Treatment C, Treatment D, Treatment E |
| AcarboseAlso: Glucobay | Drug | Treatment B |
| Japanese diet | Other | Treatment C |
Primary outcome
AUC0-∞ (area under the concentration time curve of the analyte in plasma in plasma over the time interval from 0 to infinity)
Time frame: up to 48 hours after drug administration
AUC0-48 (area under the concentration time curve of the analyte in plasma over the time interval from 0 to 48 h)
Time frame: up to 48 hours after drug administration
AUC0-12 (area under the concentration time curve of the analyte in plasma over the time interval from 0 to 12 h)
Time frame: up to 48 hours after drug administration
Cmax (maximum concentration of the analyte in plasma)
Time frame: up to 48 hours after drug administration
16 secondary outcomes
tmax (time from dosing to maximum concentration of the analyte in plasma)
Time frame: up to 48 hours after drug administration
λz (terminal rate constant in plasma after single dose
Time frame: up to 48 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma after single dose)
Time frame: up to 48 hours after drug administration
MRTpo (mean residence time of the analyte in the body after single dose)
Time frame: up to 48 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration after single dose)
Time frame: up to 48 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz after single dose following extravascular administration)
Time frame: up to 48 hours after drug administration
AUCt1-t2 (area under the concentration time curve of analyte in plasma over the time interval t1 to t2)
Time frame: up to 24 hours after drug administration
Aet1-t2 (amount of drug that is eliminated in urine from the time point t1 to time point t2)
Time frame: up to 24 hours after drug administration
fet1-t2 (fraction of drug eliminated in urine from time point t1 to time point t2)
Time frame: up to 24 hours after drug administration
CLR,t1-t2 (renal clearance of the drug from the time point t1 until the time point t2)
Time frame: up to 24 hours after drug administration
Amount of glucose excreted in urine
Time frame: up to 24 hours after drug administration
Number of patients with adverse events
Time frame: up to 48 hours after last administration of study drug
Number of patients with clinically relevant changes in laboratory tests
Time frame: up to 48 hours after last administration of study drug
Number of patients with clinically relevant changes in Electrocardiogram (ECG)
Time frame: up to 48 hours after last administration of study drug
Number of patients with clinically relevant changes in vital signs
Time frame: up to 48 hours after last administration of study drug
Assessment of global tolerability by investigator on a 4-point scale
Time frame: 48 hours after last administration of study drug
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 8 Aug 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 BI 44847, Acarbose and Japanese diet 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 19 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 8 Aug 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-∞ (area under the concentration time curve of the analyte in plasma in plasma over the time interval from 0 to infinity) (time frame: up to 48 hours after drug administration). 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 8 Aug 2014; AzTrials last refreshed its copy on 7 Nov 2026.