Diabetes Mellitus, Type 2Phase 1NCT01146886
Trial to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of BI135585 XX Administered as Tablet and as Solution in Healthy Volunteers
A Phase 1 study testing BI 135585 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
The purpose of the study is to investigate the safety, tolerability, pharmacokinetics incl. dose proportionality, and pharmacodynamics of BI 135585 XX (Part 1), as well as the relative bioavailability of two different immediate release tablet formulations versus oral solution (Part 2) Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- BI 135585
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2010to Sep 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male volunteers
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of 10 mg to 1200 mg of BI 135585 XX Administered as a Solution to Healthy Male Volunteers (Trial Part 1), Followed by an Open, Randomised, Single-dose, Intra-individual Bioavailability Comparison of 200 mg BI 135585 XX as Tablet and as Solution (Trial Part 2)
The purpose of the study is to investigate the safety, tolerability, pharmacokinetics incl. dose proportionality, and pharmacodynamics of BI 135585 XX (Part 1), as well as the relative bioavailability of two different immediate release tablet formulations versus oral solution (Part 2)
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Placebo to BI 135585, BI 135585
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo to BI 135585Drug
Part 1 - oral doses given to approximately 9 parallel groups of 8 subjects (6 on active and 2 on on placebo) on Day 1
BI 135585Drug
Part 1 - oral doses given to approximately 9 parallel groups of 8 subjects (6 on active and 2 on placebo) on Day 1; Part 2 - oral doses given to 12 subjects on Day 1
| Study group | Role | What they receive |
|---|---|---|
| BI 135585 | Experimental | 1 single dose per subject as oral solution in Part 1, or 3 single doses per subject as oral solution and 2 different tablet formulations in Part 2 Receives: Drug: BI 135585 |
| Placebo to BI 135585 | Placebo comparator | 1 single dose per subject as oral solution in Part 1 Receives: Drug: Placebo to BI 135585 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Physical examination (occurrence of findings)
Measured: up to 14 days post treatment
Change from baseline in Vital signs (blood pressure [BP], pulse rate [PR], respiratory rate [RR])
Measured: up to 14 days post treatment
Change from baseline in 12-lead ECG with special attention to QTc prolongation
Measured: up to 14 days post treatment
Cardiopulmonary monitoring resulting in clinically relevant findings
Measured: up to 14 days post treatment
Change from baseline in Clinical laboratory parameters including hormones of the HPA axis and thyroid gland
Measured: up to 14 days post treatment
Number of patients with Adverse events (AE)
Measured: up to 14 days post treatment
Assessment of tolerability by the investigator
Measured: up to 14 days post treatment
Secondary outcomes (16)
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 72 hours post treatment
(5α-THF + 5β-THF)/THE ratio as an indicator of 11β-HSD1 inhibition
Measured: up to 24h
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Measured: up to 72 hours post treatment
Cmax (maximum measured concentration of the analyte in plasma)
Measured: up to 72 hours post treatment
tmax (time from dosing to maximum measured concentration)
Measured: up to 72 hours post treatment
%AUCtz-∞ (percentage of the AUC0-∞ that was obtained by extrapolation)
Measured: up to 72 hours post treatment
λz (terminal rate constant in plasma)
Measured: up to 72 hours post treatment
t1/2 (terminal half-life of the analyte in plasma)
Measured: up to 72 hours post treatment
MRToral (mean residence time of the analyte in the body after oral administration)
Measured: up to 72 hours post treatment
CL/F (total/apparent clearance of the analyte in plasma after extravascular administration)
Measured: up to 72 hours post treatment
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: up to 72 hours post treatment
Aet1-t2 (amount of analyte eliminated in urine from timepoint t1 to timepoint t2) SRD part only
Measured: up to 72 hours post treatment
fet1-t2 (fraction of analyte eliminated in urine from timepoint t1 to timepoint t2) SRD part only
Measured: up to 72 hours post treatment
CLR,t1-t2 (renal clearance of the analyte from timepoint t1 to timepoint t2) SRD part only[
Measured: up to 72 hours post treatment
UFF/UFE ratio as an indicator of 11β-HSD2 inhibition
Measured: up to 24h
Total urinary corticosteroids (5α-THF + 5β-THF + THE + UFF + UFE) as an indicator of the activation of the HPA axis
Measured: up to 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146886
- Sponsor's protocol ID
- 1283.1
- Other IDs
- 2010-018856-28
- Status last verified
- Oct 2013
- First submitted
- 14 Jun 2010
- Last updated
- 1 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of 10 mg to 1200 mg of BI 135585 XX Administered as a Solution to Healthy Male Volunteers (Trial Part 1), Followed by an Open, Randomised, Single-dose, Intra-individual Bioavailability Comparison of 200 mg BI 135585 XX as Tablet and as Solution (Trial Part 2)
- ClinicalTrials.gov ID
- NCT01146886
- Acronym / sponsor ID
- 1283.1
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Sep 2010 (actual)
- First posted
- 22 Jun 2010 (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 purpose of the study is to investigate the safety, tolerability, pharmacokinetics incl. dose proportionality, and pharmacodynamics of BI 135585 XX (Part 1), as well as the relative bioavailability of two different immediate release tablet formulations versus oral solution (Part 2)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 135585 | Experimental | Drug: BI 1355851 single dose per subject as oral solution in Part 1, or 3 single doses per subject as oral solution and 2 different tablet formulations in Part 2 |
| Placebo to BI 135585 | Placebo comparator | Drug: Placebo to BI 1355851 single dose per subject as oral solution in Part 1 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy male volunteers
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Placebo to BI 135585Part 1 - oral doses given to approximately 9 parallel groups of 8 subjects (6 on active and 2 on on placebo) on Day 1 | Drug | Placebo to BI 135585 |
| BI 135585Part 1 - oral doses given to approximately 9 parallel groups of 8 subjects (6 on active and 2 on placebo) on Day 1; Part 2 - oral doses given to 12 subjects on Day 1 | Drug | BI 135585 |
Primary outcome
Change from baseline in Physical examination (occurrence of findings)
Time frame: up to 14 days post treatment
Change from baseline in Vital signs (blood pressure [BP], pulse rate [PR], respiratory rate [RR])
Time frame: up to 14 days post treatment
Change from baseline in 12-lead ECG with special attention to QTc prolongation
Time frame: up to 14 days post treatment
Cardiopulmonary monitoring resulting in clinically relevant findings
Time frame: up to 14 days post treatment
Change from baseline in Clinical laboratory parameters including hormones of the HPA axis and thyroid gland
Time frame: up to 14 days post treatment
Number of patients with Adverse events (AE)
Time frame: up to 14 days post treatment
Assessment of tolerability by the investigator
Time frame: up to 14 days post treatment
16 secondary outcomes
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 72 hours post treatment
(5α-THF + 5β-THF)/THE ratio as an indicator of 11β-HSD1 inhibition
Time frame: up to 24h
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: up to 72 hours post treatment
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 72 hours post treatment
tmax (time from dosing to maximum measured concentration)
Time frame: up to 72 hours post treatment
%AUCtz-∞ (percentage of the AUC0-∞ that was obtained by extrapolation)
Time frame: up to 72 hours post treatment
λz (terminal rate constant in plasma)
Time frame: up to 72 hours post treatment
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 72 hours post treatment
MRToral (mean residence time of the analyte in the body after oral administration)
Time frame: up to 72 hours post treatment
CL/F (total/apparent clearance of the analyte in plasma after extravascular administration)
Time frame: up to 72 hours post treatment
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 72 hours post treatment
Aet1-t2 (amount of analyte eliminated in urine from timepoint t1 to timepoint t2) SRD part only
Time frame: up to 72 hours post treatment
fet1-t2 (fraction of analyte eliminated in urine from timepoint t1 to timepoint t2) SRD part only
Time frame: up to 72 hours post treatment
CLR,t1-t2 (renal clearance of the analyte from timepoint t1 to timepoint t2) SRD part only[
Time frame: up to 72 hours post treatment
UFF/UFE ratio as an indicator of 11β-HSD2 inhibition
Time frame: up to 24h
Total urinary corticosteroids (5α-THF + 5β-THF + THE + UFF + UFE) as an indicator of the activation of the HPA axis
Time frame: up to 24h
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 1 Nov 2013.
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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 BI 135585 in people with Diabetes Mellitus, Type 2, 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 1 inclusion and 0 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 1 Nov 2013. 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. Some participants in this study may receive a placebo. 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?
Change from baseline in Physical examination (occurrence of findings) (time frame: up to 14 days post treatment). The study lists 7 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 1 Nov 2013.