HealthyPhase 1NCT02172196
Bioavailability of BI 10773 and Sitagliptin in Healthy Male Volunteers
A Phase 1 study testing BI 10773 and Sitagliptin in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objective was to investigate whether there was a drug-drug interaction between BI 10773 and sitagliptin when co-administered as multiple oral doses. Therefore, the relative bioavailabilities of BI 10773 and sitagliptin were determined when both drugs were given in combination compared with BI 10773 or sitagliptin… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 10773 and Sitagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Jul 2009
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- Age 18 to 50 years (incl.)
- BMI 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation
Who cannot join
- Any finding of the medical examination deviating from normal and of clinical relevance. Repeated measurement of a systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
Show all 19Show fewer
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Intake of drugs within one month or less than 10 half-lives of the respective drug prior to first study drug administration except if a relevant interaction can be ruled out
- Participation in another trial with an investigational drug within two months prior to first study drug administration
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (average consumption of more than 30 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to the start of study)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
- A history of additional risk factors for TdP (Torsades de pointes) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
About this study
Official title: Relative Bioavailability of Both BI 10773 and Sitagliptin After Co-administration Compared to Multiple Oral Doses of BI 10773 (50 mg q.d.) Alone and Sitagliptin (100 mg q.d.) Alone in Healthy Male Volunteers (an Open-label, Randomised, Crossover, Clinical Phase I Study)
The objective was to investigate whether there was a drug-drug interaction between BI 10773 and sitagliptin when co-administered as multiple oral doses. Therefore, the relative bioavailabilities of BI 10773 and sitagliptin were determined when both drugs were given in combination compared with BI 10773 or sitagliptin given alone.
- Conditions
- Healthy
- Being tested
- BI 10773, Sitagliptin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 10773Drug
SitagliptinDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence ABC | Experimental | 1. Treatment A: BI 10773 once daily from day 1 to 5
2. Treatment B: BI 10773 and sitagliptin once daily from day 1 to 5
3. Treatment C: Sitagliptin once daily from day 1 to 5 Receives: Drug: BI 10773; Drug: Sitagliptin |
| Treatment sequence CAB | Experimental | 1. Treatment C: Sitagliptin once daily from day 1 to 5
2. Treatment A: BI 10773 once daily from day 1 to 5
3. Treatment B: BI 10773 and sitagliptin once daily from day 1 to 5 Receives: Drug: BI 10773; Drug: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Measured: Days 1-8
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Measured: Days 1-8
Secondary outcomes (17)
C24,N (concentration of analyte in plasma at 24 hours post-drug administration after administration of the Nth dose)
Measured: Days 1-8
λz,ss (terminal half-life of the analyte in plasma)
Measured: Days 1-8
t½,ss (terminal half-life of the analyte in plasma at steady state)
Measured: Days 1-8
tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Measured: Days 1-8
MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)
Measured: Days 1-8
CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)
Measured: Days 1-8
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)
Measured: Days 1-8
Aet1-t2,ss (amount of analyte eliminated in urine at steady state over a uniform dosing interval τ)
Measured: 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing
fet1-t2,ss (fraction of analyte excreted unchanged in urine at steady state over a uniform dosing interval τ)
Measured: 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing
CLR,ss (renal clearance of the analyte at steady state)
Measured: 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing
UGE0-24 (Urinary glucose excretion of the analyte in urine over the time interval from time zero to 24 h)
Measured: 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing
Abnormal findings in physical examination
Measured: Baseline and within 3-10 days after last study drug administration
Changes from baseline in vital sings (blood pressure, pulse rate)
Measured: Baseline, day 1 and within 3-10 days after last study drug administration
Changes from baseline in 12-lead ECG (electrocardiogram)
Measured: Baseline and within 3-10 days after last study drug administration
Changes from baseline in clinical laboratory tests
Measured: Baseline, day 1, 5 and within 3-10 days after last study drug administration
Incidence of adverse events
Measured: up to 28 days
Assessment of tolerability by investigator on a 4-point scale
Measured: Within 3-10 days after last study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startMay 2009
- Primary completionJul 2009
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
- None (open label)
- Enrolment
- 16 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
- NCT02172196
- Sponsor's protocol ID
- 1245.27
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of Both BI 10773 and Sitagliptin After Co-administration Compared to Multiple Oral Doses of BI 10773 (50 mg q.d.) Alone and Sitagliptin (100 mg q.d.) Alone in Healthy Male Volunteers (an Open-label, Randomised, Crossover, Clinical Phase I Study)
- ClinicalTrials.gov ID
- NCT02172196
- Acronym / sponsor ID
- 1245.27
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jul 2009 (actual)
- First posted
- 24 Jun 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 was to investigate whether there was a drug-drug interaction between BI 10773 and sitagliptin when co-administered as multiple oral doses. Therefore, the relative bioavailabilities of BI 10773 and sitagliptin were determined when both drugs were given in combination compared with BI 10773 or sitagliptin given alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence ABC | Experimental | Drug: BI 10773, Drug: Sitagliptin1. Treatment A: BI 10773 once daily from day 1 to 5 2. Treatment B: BI 10773 and sitagliptin once daily from day 1 to 5 3. Treatment C: Sitagliptin once daily from day 1 to 5 |
| Treatment sequence CAB | Experimental | Drug: BI 10773, Drug: Sitagliptin1. Treatment C: Sitagliptin once daily from day 1 to 5 2. Treatment A: BI 10773 once daily from day 1 to 5 3. Treatment B: BI 10773 and sitagliptin once daily from day 1 to 5 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male volunteers according to the following criteria:
- Age 18 to 50 years (incl.)
- BMI 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation
Key exclusion criteria (19 listed)
- Any finding of the medical examination deviating from normal and of clinical relevance. Repeated measurement of a systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological 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 |
|---|---|---|
| BI 10773 | Drug | Treatment sequence ABC, Treatment sequence CAB |
| Sitagliptin | Drug | Treatment sequence ABC, Treatment sequence CAB |
Primary outcome
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: Days 1-8
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: Days 1-8
17 secondary outcomes
C24,N (concentration of analyte in plasma at 24 hours post-drug administration after administration of the Nth dose)
Time frame: Days 1-8
λz,ss (terminal half-life of the analyte in plasma)
Time frame: Days 1-8
t½,ss (terminal half-life of the analyte in plasma at steady state)
Time frame: Days 1-8
tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: Days 1-8
MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)
Time frame: Days 1-8
CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)
Time frame: Days 1-8
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)
Time frame: Days 1-8
Aet1-t2,ss (amount of analyte eliminated in urine at steady state over a uniform dosing interval τ)
Time frame: 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing
fet1-t2,ss (fraction of analyte excreted unchanged in urine at steady state over a uniform dosing interval τ)
Time frame: 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing
CLR,ss (renal clearance of the analyte at steady state)
Time frame: 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing
UGE0-24 (Urinary glucose excretion of the analyte in urine over the time interval from time zero to 24 h)
Time frame: 1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing
Abnormal findings in physical examination
Time frame: Baseline and within 3-10 days after last study drug administration
Changes from baseline in vital sings (blood pressure, pulse rate)
Time frame: Baseline, day 1 and within 3-10 days after last study drug administration
Changes from baseline in 12-lead ECG (electrocardiogram)
Time frame: Baseline and within 3-10 days after last study drug administration
Changes from baseline in clinical laboratory tests
Time frame: Baseline, day 1, 5 and within 3-10 days after last study drug administration
Incidence of adverse events
Time frame: up to 28 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: Within 3-10 days after last study drug administration
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 24 Jun 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 10773 and Sitagliptin 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 5 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 24 Jun 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?
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) (time frame: Days 1-8). 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 24 Jun 2014.