HealthyPhase 1NCT01581684

Safety Tolerability and Pharmacokinetic of BI 411034

A Phase 1 study testing BI 411034 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective of the current study is to investigate the safety, tolerability and pharmacokinetics of BI 411034 in healthy male volunteers following oral administration of single rising doses. 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 411034
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 62 participants
Where: 1 siteGermany
Study dates: 1 Apr 2012to 1 Aug 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

1. Healthy male subjects

Who cannot join

1. Any relevant deviation from healthy conditions

Trial locations and contacts

1 site in 1 country.

Germany1 site

1308.1.1 Boehringer Ingelheim Investigational Site
Ingelheim

Other trials in Germany

About this study

Official title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 411034 (PIB) in Healthy Male Volunteers (Randomised, Single-blind, Placebocontrolled Within Dose Groups, Phase I Study)

The secondary objective is to explore dose proportionality of BI 411034 in CYP2C19 (Cytochrome P450) genotyped extensive metabolisers (EM).

Another objective is to compare the safety and pharmacokinetic profiles between two different groups of CYP2C19 genotyped subjects, extensive metabolisers (EM) and poor metabolisers (PM)

Conditions: Healthy
Being tested: BI 411034, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 411034Drug
Low dose solution for oral administration
PlaceboDrug
Solution for oral administration
BI 411034Drug
Medium dose solution for oral administration
BI 411034Drug
Low dose solution for oral administration
BI 411034Drug
High dose solution for oral administration
BI 411034Drug
High dose solution for oral administration
BI 411034Drug
Medium dose solution for oral administration
BI 411034Drug
High dose solution for oral administration
BI 411034Drug
Medium dose solution for oral administration

Study groups in NCT01581684
Study group	Role	What they receive
BI 411034 low dose - group 1	Experimental	Solution for oral administration Receives: Drug: BI 411034
BI 411034 low dose - group 2	Experimental	Solution for oral administration Receives: Drug: BI 411034
BI 411034 medium dose - group 3	Experimental	Solution for oral administration Receives: Drug: BI 411034
BI 411034 medium dose - group 4	Experimental	Solution for oral administration Receives: Drug: BI 411034
BI 411034 medium dose - group 5	Experimental	Solution for oral administration Receives: Drug: BI 411034
BI 411034 high dose - group 6	Experimental	Solution for oral administration Receives: Drug: BI 411034
BI 411034 high dose - group 7	Experimental	Solution for oral administration Receives: Drug: BI 411034
BI 411034 high dose - group 8	Experimental	Solution for oral administration Receives: Drug: BI 411034
Placebo	Placebo comparator	Solution for oral administration Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Drug Related AEs
Number of participants with drug related adverse events (AEs)
Measured: From drug administration until end of trial examination, up to 13 days
Clinically Relevant Abnormalities for Physical Examinations, Vital Signs, ECG, Laboratory Tests
Clinically relevant abnormalities for physical examinations, vital signs (blood pressure, pulse rate, oral body temperature, orthostasis test), 12-lead electrocardiogram (ECG) and clinical laboratory tests. Clinically relevant abnormalities are reported by the investigator as adverse events (AEs).
Measured: From drug administration until end of trial examination, up to 13 days

Secondary outcomes (4)

Maximum Measured Concentration (Cmax )
Maximum measured concentration of the analyte (BI 411034) in plasma
Measured: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
Time to Maximum Measured Concentration (Tmax)
Time from dosing to maximum measured concentration
Measured: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
Area Under the Curve From 0 Extrapolated to Infinity (AUC0-infinity)
Area under the concentration-time curve of the analyte (BI 411034) in plasma over the time interval from 0 extrapolated to infinity
Measured: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
Amount of Analyte Eliminated in Urine From 0h to 4h (Ae0-4)
Amount of analyte (BI 411034) eliminated in urine from the time point 0h to time point 4h.
Measured: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20121 Aug 2012

First posted20 Apr 2012 (estimated)
Study start1 Apr 2012
Primary completion1 Aug 2012
Study completion1 Aug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Single group
Masking: Single blind
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01581684
Sponsor's protocol ID: 1308.1
Other IDs: 2011-004840-23
Status last verified: Jul 2017
First submitted: 19 Apr 2012
Last updated: 15 Aug 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 411034 (PIB) in Healthy Male Volunteers (Randomised, Single-blind, Placebocontrolled Within Dose Groups, Phase I Study)
ClinicalTrials.gov ID: NCT01581684
Acronym / sponsor ID: 1308.1
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 1 Apr 2012 (actual)
Primary completion: 1 Aug 2012 (actual)
Study completion: 1 Aug 2012 (actual)
First posted: 20 Apr 2012 (estimated)
Results: Posted 17 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The secondary objective is to explore dose proportionality of BI 411034 in CYP2C19 (Cytochrome P450) genotyped extensive metabolisers (EM).

Another objective is to compare the safety and pharmacokinetic profiles between two different groups of CYP2C19 genotyped subjects, extensive metabolisers (EM) and poor metabolisers (PM)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Number of arms: 9

Arm	Type	Receives
BI 411034 low dose - group 1	Experimental	Drug: BI 411034Solution for oral administration
BI 411034 low dose - group 2	Experimental	Drug: BI 411034Solution for oral administration
BI 411034 medium dose - group 3	Experimental	Drug: BI 411034Solution for oral administration
BI 411034 medium dose - group 4	Experimental	Drug: BI 411034Solution for oral administration
BI 411034 medium dose - group 5	Experimental	Drug: BI 411034Solution for oral administration
BI 411034 high dose - group 6	Experimental	Drug: BI 411034Solution for oral administration
BI 411034 high dose - group 7	Experimental	Drug: BI 411034Solution for oral administration
BI 411034 high dose - group 8	Experimental	Drug: BI 411034Solution for oral administration
Placebo	Placebo comparator	Drug: PlaceboSolution for oral administration

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

1. Healthy male subjects

Key exclusion criteria (1 listed)

1. Any relevant deviation from healthy conditions

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 411034Low dose solution for oral administration	Drug	BI 411034 low dose - group 2
PlaceboSolution for oral administration	Drug	Placebo
BI 411034Medium dose solution for oral administration	Drug	BI 411034 medium dose - group 3
BI 411034Low dose solution for oral administration	Drug	BI 411034 low dose - group 1
BI 411034High dose solution for oral administration	Drug	BI 411034 high dose - group 6
BI 411034High dose solution for oral administration	Drug	BI 411034 high dose - group 7
BI 411034Medium dose solution for oral administration	Drug	BI 411034 medium dose - group 5
BI 411034High dose solution for oral administration	Drug	BI 411034 high dose - group 8
BI 411034Medium dose solution for oral administration	Drug	BI 411034 medium dose - group 4

Primary outcome

Number of Participants With Drug Related AEs
Time frame: From drug administration until end of trial examination, up to 13 days
Number of participants with drug related adverse events (AEs)
Clinically Relevant Abnormalities for Physical Examinations, Vital Signs, ECG, Laboratory Tests
Time frame: From drug administration until end of trial examination, up to 13 days
Clinically relevant abnormalities for physical examinations, vital signs (blood pressure, pulse rate, oral body temperature, orthostasis test), 12-lead electrocardiogram (ECG) and clinical laboratory tests. Clinically relevant abnormalities are reported by the investigator as adverse events (AEs).

4 secondary outcomes

Maximum Measured Concentration (Cmax )
Time frame: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
Time to Maximum Measured Concentration (Tmax)
Time frame: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
Area Under the Curve From 0 Extrapolated to Infinity (AUC0-infinity)
Time frame: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
Amount of Analyte Eliminated in Urine From 0h to 4h (Ae0-4)
Time frame: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration

Results and safety

Results posted to the registry on 17 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo EM	14	14
2mg EM	6	6
8mg EM	6	6
20mg EM	6	6
40mg EM	6	6
80mg EM	6	6
150mg EM	6	6
250mg EM	6	6
Placebo PM	1	0
20/60mg PM	5	5

Primary outcome: Number of Participants With Drug Related AEs

Time frame: From drug administration until end of trial examination, up to 13 days. Number. Unit: participants

Measure	Placebo EM n = 14	2mg EM n = 6	8mg EM n = 6	20mg EM n = 6	40mg EM n = 6	80mg EM n = 6	150mg EM n = 6	250mg EM n = 6	Placebo PM n = 1	20mg PM n = 5	60mg PM n = 5
Value	1	0	0	1	1	1	2	3	0	0	2

Population analysed: Treated set which included all subjects who were administered trial medication and were documented to have taken the dose of investigational treatment

Primary outcome: Clinically Relevant Abnormalities for Physical Examinations, Vital Signs, ECG, Laboratory Tests

Time frame: From drug administration until end of trial examination, up to 13 days. Number. Unit: participants

Measure	Placebo EM n = 14	2mg EM n = 6	8mg EM n = 6	20mg EM n = 6	40mg EM n = 6	80mg EM n = 6	150mg EM n = 6	250mg EM n = 6	Placebo PM n = 1	20mg PM n = 5	60mg PM n = 5
Value	0	0	0	0	0	0	0	0	0	0	0

Population analysed: Treated set

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From drug administration until end of trial examination, up to 13 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo EM	0 of 14 (0%)	3 of 14 (21.4%)	Not reported
2mg EM	0 of 6 (0%)	0 of 6 (0%)	Not reported
8mg EM	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
20mg EM	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
40mg EM	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
80mg EM	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
150mg EM	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
250mg EM	0 of 6 (0%)	3 of 6 (50%)	Not reported
Placebo PM	0 of 1 (0%)	1 of 1 (100%)	Not reported
20mg PM	0 of 5 (0%)	0 of 5 (0%)	Not reported
60mg PM	0 of 5 (0%)	3 of 5 (60%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 411034 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 1 inclusion and 1 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 15 Aug 2017. 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?

Yes. Results are posted in the registry (first posted 17 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Drug Related AEs (time frame: From drug administration until end of trial examination, up to 13 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?

On the ClinicalTrials.gov record for NCT01581684.

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 15 Aug 2017.