HealthyPhase 1NCT02172235
Relative Bioavailability of Pioglitazone After Co-administration With Different Doses of BI 10773 in Healthy Volunteers
A Phase 1 study testing Pioglitazone, Pioglitazone - low dose and BI 10773 - low dose in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objective was to investigate the effect of different doses of BI 10773 on the bioavailability of pioglitazone after multiple oral doses of both drugs 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?
- Pioglitazone, Pioglitazone - low dose and BI 10773 - low dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Jul 2010
- 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 following criteria:
- medical history, physical examination, vital signs ((blood pressure (BP), pulse rate (PR), 12-lead electrocardiogram (ECG)), clinical laboratory tests
- Age 18 to 55 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 Good Clinical Practise (GCP) and the local legislation
Who cannot join
- Any finding of the medical examination including blood pressure (BP), pulse rate (PR) and electrocardiogram (ECG) deviating from normal and of clinical relevance
- 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 with a long half-life (more than 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (more than 10 cigarettes or more than 3 cigars or more than 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 30 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Alanine aminotransferase (ALT) outside the normal range or any other laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial site
- Galactose or lactose intolerance, galactose or glucose malabsorption
About this study
Official title: Relative Bioavailability of Pioglitazone After Co-administration With Different Doses of BI 10773 in Healthy Volunteers (an Open-label, Randomised, Crossover, Clinical Phase I Study)
The objective was to investigate the effect of different doses of BI 10773 on the bioavailability of pioglitazone after multiple oral doses of both drugs
- Conditions
- Healthy
- Being tested
- Pioglitazone, Pioglitazone - low dose, BI 10773 - low dose, BI 10773 - medium dose, BI 10773 - high dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
Pioglitazone - low doseDrug
BI 10773 - low doseDrug
BI 10773 - medium doseDrug
BI 10773 - high doseDrug
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone | Active comparator | Not described Receives: Drug: Pioglitazone |
| Pioglitazone + BI 10773 low | Experimental | Not described Receives: Drug: Pioglitazone; Drug: BI 10773 - low dose |
| Pioglitazone + BI 10773 medium | Experimental | Not described Receives: Drug: Pioglitazone; Drug: BI 10773 - medium dose |
| Pioglitazone + BI 10773 high | Experimental | Not described Receives: Drug: Pioglitazone; Drug: BI 10773 - high dose |
| Pioglitazone low + BI 10773 medium | Experimental | Not described Receives: Drug: Pioglitazone - low dose; Drug: BI 10773 - medium dose |
| Pioglitazone + BI 10773 1 hour after Pioglitazone | Experimental | Not described Receives: Drug: Pioglitazone; Drug: BI 10773 - medium dose |
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: Before each dosing, up to 10 days
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Measured: Before each dosing, up to 10 days
Secondary outcomes (21)
C24,N (concentration of the analyte in plasma at 24 h after administration of the Nth dose)
Measured: Before each dosing, up to 10 days
λz (terminal elimination rate constant of the analyte in plasma)
Measured: Before each dosing, up to 10 days
t½ (terminal half-life of the analyte in plasma)
Measured: Before each dosing, up to 10 days
tmax (time from last dosing to maximum measured concentration of the analyte in plasma)
Measured: Before each dosing, up to 10 days
MRTpo (mean residence time of the analyte in the body at steady state after oral administration)
Measured: Before each dosing, up to 10 days
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Measured: Before each dosing, up to 10 days
Vz/F (apparent volume of distribution during the terminal phase λz following extravascular administration)
Measured: Before each dosing, up to 10 days
Aet1-t2 (amount of analyte eliminated in urine over the time interval t1 to t2 )
Measured: Day1 (-1-0, 0-4, 4-8, 8-12, and 12-24 h), Day 7 (143-144, 144-148, 148-152, 152-156, and 156-168 h)
fet1-t2 (fraction of dose excreted unchanged in urine over the time interval t1 to t2)
Measured: Day1 (-1-0, 0-4, 4-8, 8-12, and 12-24 h), Day 7 (143-144, 144-148, 148-152, 152-156, and 156-168 h)
CLR (renal clearance of the analyte in plasma afer extravascular administration)
Measured: Day1 (-1-0, 0-4, 4-8, 8-12, and 12-24 h), Day 7 (143-144, 144-148, 148-152, 152-156, and 156-168 h)
Cmax (maximum concentration of the analyte in plasma)
Measured: Before each dosing, up to 10 days
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable plasma concentration)
Measured: Before each dosing, up to 10 days
AUCτ,1 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable plasma concentration within the first dosing interval)
Measured: Before each dosing, up to 10 days
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: Before each dosing, up to 10 days
Metabolite to parent ratio
Measured: Before each dosing, up to 10 days
Number of patients with abnormal findings in physical examination
Measured: up to 30 days after drug administration
Number of patients with abnormal changes in laboratory parameters
Measured: up to 30 days after drug administration
Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)
Measured: up to 30 days after drug administration
Number of patients with clinically significant changes in vital signs
Measured: up to 30 days after drug administration
Assessment of tolerability by investigator on a 4-point scale
Measured: up to 10 days
Number of patients with adverse events
Measured: up to 51 days
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 startApr 2010
- Primary completionJul 2010
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
- 20 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
- NCT02172235
- Sponsor's protocol ID
- 1245.50
- 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 Pioglitazone After Co-administration With Different Doses of BI 10773 in Healthy Volunteers (an Open-label, Randomised, Crossover, Clinical Phase I Study)
- ClinicalTrials.gov ID
- NCT02172235
- Acronym / sponsor ID
- 1245.50
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jul 2010 (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 the effect of different doses of BI 10773 on the bioavailability of pioglitazone after multiple oral doses of both drugs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone | Active comparator | Drug: Pioglitazone |
| Pioglitazone + BI 10773 low | Experimental | Drug: Pioglitazone, Drug: BI 10773 - low dose |
| Pioglitazone + BI 10773 medium | Experimental | Drug: Pioglitazone, Drug: BI 10773 - medium dose |
| Pioglitazone + BI 10773 high | Experimental | Drug: Pioglitazone, Drug: BI 10773 - high dose |
| Pioglitazone low + BI 10773 medium | Experimental | Drug: Pioglitazone - low dose, Drug: BI 10773 - medium dose |
| Pioglitazone + BI 10773 1 hour after Pioglitazone | Experimental | Drug: Pioglitazone, Drug: BI 10773 - medium dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male subjects according to the following criteria:
- medical history, physical examination, vital signs ((blood pressure (BP), pulse rate (PR), 12-lead electrocardiogram (ECG)), clinical laboratory tests
- Age 18 to 55 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 Good Clinical Practise (GCP) and the local legislation
Key exclusion criteria (19 listed)
- Any finding of the medical examination including blood pressure (BP), pulse rate (PR) and electrocardiogram (ECG) deviating from normal and of clinical relevance
- 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 |
|---|---|---|
| Pioglitazone | Drug | Pioglitazone, Pioglitazone + BI 10773 1 hour after Pioglitazone, Pioglitazone + BI 10773 high, Pioglitazone + BI 10773 low, Pioglitazone + BI 10773 medium |
| Pioglitazone - low dose | Drug | Pioglitazone low + BI 10773 medium |
| BI 10773 - low dose | Drug | Pioglitazone + BI 10773 low |
| BI 10773 - medium dose | Drug | Pioglitazone + BI 10773 1 hour after Pioglitazone, Pioglitazone + BI 10773 medium, Pioglitazone low + BI 10773 medium |
| BI 10773 - high dose | Drug | Pioglitazone + BI 10773 high |
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: Before each dosing, up to 10 days
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: Before each dosing, up to 10 days
21 secondary outcomes
C24,N (concentration of the analyte in plasma at 24 h after administration of the Nth dose)
Time frame: Before each dosing, up to 10 days
λz (terminal elimination rate constant of the analyte in plasma)
Time frame: Before each dosing, up to 10 days
t½ (terminal half-life of the analyte in plasma)
Time frame: Before each dosing, up to 10 days
tmax (time from last dosing to maximum measured concentration of the analyte in plasma)
Time frame: Before each dosing, up to 10 days
MRTpo (mean residence time of the analyte in the body at steady state after oral administration)
Time frame: Before each dosing, up to 10 days
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: Before each dosing, up to 10 days
Vz/F (apparent volume of distribution during the terminal phase λz following extravascular administration)
Time frame: Before each dosing, up to 10 days
Aet1-t2 (amount of analyte eliminated in urine over the time interval t1 to t2 )
Time frame: Day1 (-1-0, 0-4, 4-8, 8-12, and 12-24 h), Day 7 (143-144, 144-148, 148-152, 152-156, and 156-168 h)
fet1-t2 (fraction of dose excreted unchanged in urine over the time interval t1 to t2)
Time frame: Day1 (-1-0, 0-4, 4-8, 8-12, and 12-24 h), Day 7 (143-144, 144-148, 148-152, 152-156, and 156-168 h)
CLR (renal clearance of the analyte in plasma afer extravascular administration)
Time frame: Day1 (-1-0, 0-4, 4-8, 8-12, and 12-24 h), Day 7 (143-144, 144-148, 148-152, 152-156, and 156-168 h)
Cmax (maximum concentration of the analyte in plasma)
Time frame: Before each dosing, up to 10 days
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable plasma concentration)
Time frame: Before each dosing, up to 10 days
AUCτ,1 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable plasma concentration within the first dosing interval)
Time frame: Before each dosing, up to 10 days
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: Before each dosing, up to 10 days
Metabolite to parent ratio
Time frame: Before each dosing, up to 10 days
Number of patients with abnormal findings in physical examination
Time frame: up to 30 days after drug administration
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 30 days after drug administration
Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)
Time frame: up to 30 days after drug administration
Number of patients with clinically significant changes in vital signs
Time frame: up to 30 days after drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: up to 10 days
Number of patients with adverse events
Time frame: up to 51 days
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 Pioglitazone, Pioglitazone - low dose and BI 10773 - low dose 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: Before each dosing, up to 10 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 24 Jun 2014.