HealthyPhase 1NCT01540825

First in Man Trial of BI 113608

A Phase 1 study testing BI 113608 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 and tolerability of BI 113608 in healthy male volunteers following oral administration of single rising doses. A secondary objective is the exploration of the pharmacokinetics of BI 113608 after single dosing. 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 113608
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteGermany
Study dates: Feb 2012to May 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

Boehringer Ingelheim Investigational Site
Mannheim

Other trials in Germany

About this study

Official title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 113608 in Healthy Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)

The primary objective of the current study is to investigate the safety and tolerability of BI 113608 in healthy male volunteers following oral administration of single rising doses.

A secondary objective is the exploration of the pharmacokinetics of BI 113608 after single dosing.

Conditions: Healthy
Being tested: BI 113608, Placebo

What participants receive

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

BI 113608Drug
Low dose powder for oral solution
BI 113608Drug
High dose powder for oral solution
BI 113608Drug
Medium dose powder for oral solution
BI 113608Drug
Low dose powder for oral solution
PlaceboDrug
Powder for oral solution
BI 113608Drug
Low dose powder for oral solution
BI 113608Drug
High dose powder for oral solution
BI 113608Drug
High dose powder for oral solution
BI 113608Drug
Medium dose powder for oral solution
BI 113608Drug
Medium dose powder for oral solution
BI 113608Drug
Low dose powder for oral solution

Study groups in NCT01540825
Study group	Role	What they receive
BI 113608 high dose 1	Experimental	Powder for oral solution Receives: Drug: BI 113608
BI 113608 low dose 1	Experimental	Powder for oral solution Receives: Drug: BI 113608
BI 113608 low dose 2	Experimental	Powder for oral solution Receives: Drug: BI 113608
BI 113608 low dose 4	Experimental	Powder for oral solution Receives: Drug: BI 113608
BI 113608 low dose 5	Experimental	Powder for oral solution Receives: Drug: BI 113608
BI 113608 medium dose 1	Experimental	Powder for oral solution Receives: Drug: BI 113608
BI 113608 medium dose 2	Experimental	Powder for oral solution Receives: Drug: BI 113608
BI 113608 medium dose 3	Experimental	Powder for oral solution Receives: Drug: BI 113608
BI 113608 high dose 2	Experimental	Powder for oral solution Receives: Drug: BI 113608
BI 113608 high dose 3	Experimental	Powder for oral solution Receives: Drug: BI 113608
Placebo	Placebo comparator	Powder for oral solution Receives: Drug: Placebo

What is being measured

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

Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, Lung Function, Carbon Monoxide Diffusing Capacity of the Lung, ECG, Physical Examination, Orthostasis Test, Oxygen Saturation or Haemoccult Test
Clinically relevant abnormalities for clinical laboratory evaluation, vital signs, lung function, carbon monoxide Diffusing Capacity Of the Lung (DLCO), Electrocardiogram (ECG), physical examination, orthostasis test, oxygen saturation or haemoccult test
Measured: From administration of study drug until end-of-study visit, up to 10 days
Percentage of Participants With Drug-related Adverse Events
Percentage of participants with drug-related adverse events
Measured: From administration of study drug until end-of-study visit, up to 10 days
Assessment of Tolerability by the Investigator
Assessment of tolerability by the investigator assessed according to the categories good, satisfactory, not satisfactory, bad and not assessable.
Measured: End of study visit, up to day 10

Secondary outcomes (5)

Cmax
Maximum measured concentration of the analyte in plasma (Cmax).
The analysis population was the pharmacokinetic (PK) set which included all subjects randomised and treated with study medication who provided at least 1 evaluable observation for a PK endpoint of Area Under the Concentration-time Curve from 0 to infinity (AUC0-inf), Area Under the Concentration-time Curve from 0 to the last quantifiable data point (AUC0-tz) and Cmax and who had no important protocol violations relevant to the evaluation of PK.
Measured: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration
Tmax
Time from dosing to maximum measured concentration of the analyte in plasma (Tmax)
Measured: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration
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 (AUC0-tz)
Measured: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration
AUC0-infinity
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity)
Measured: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration
t1/2
Terminal half-life of the analyte in plasma (t1/2)
Measured: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration

Timeline

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

Feb 2012May 2012

First posted29 Feb 2012 (estimated)
Study startFeb 2012
Primary completionMay 2012
Study completionMay 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: Parallel groups
Masking: Double blind
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01540825
Sponsor's protocol ID: 1314.1
Other IDs: 2011-005034-19
Status last verified: Nov 2016
First submitted: 13 Feb 2012
Last updated: 20 Jan 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 20 Jan 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 113608 in Healthy Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)
ClinicalTrials.gov ID: NCT01540825
Acronym / sponsor ID: 1314.1
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 29 Feb 2012 (estimated)
Results: Posted 20 Jan 2017

Clinical summary

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

The primary objective of the current study is to investigate the safety and tolerability of BI 113608 in healthy male volunteers following oral administration of single rising doses.

A secondary objective is the exploration of the pharmacokinetics of BI 113608 after single dosing.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 11

Arm	Type	Receives
BI 113608 high dose 1	Experimental	Drug: BI 113608Powder for oral solution
BI 113608 low dose 1	Experimental	Drug: BI 113608Powder for oral solution
BI 113608 low dose 2	Experimental	Drug: BI 113608Powder for oral solution
BI 113608 low dose 4	Experimental	Drug: BI 113608Powder for oral solution
BI 113608 low dose 5	Experimental	Drug: BI 113608Powder for oral solution
BI 113608 medium dose 1	Experimental	Drug: BI 113608Powder for oral solution
BI 113608 medium dose 2	Experimental	Drug: BI 113608Powder for oral solution
BI 113608 medium dose 3	Experimental	Drug: BI 113608Powder for oral solution
BI 113608 high dose 2	Experimental	Drug: BI 113608Powder for oral solution
BI 113608 high dose 3	Experimental	Drug: BI 113608Powder for oral solution
Placebo	Placebo comparator	Drug: PlaceboPowder for oral solution

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 113608Low dose powder for oral solution	Drug	BI 113608 low dose 1
BI 113608High dose powder for oral solution	Drug	BI 113608 high dose 1
BI 113608Medium dose powder for oral solution	Drug	BI 113608 medium dose 3
BI 113608Low dose powder for oral solution	Drug	BI 113608 low dose 2
PlaceboPowder for oral solution	Drug	Placebo
BI 113608Low dose powder for oral solution	Drug	BI 113608 low dose 5
BI 113608High dose powder for oral solution	Drug	BI 113608 high dose 2
BI 113608High dose powder for oral solution	Drug	BI 113608 high dose 3
BI 113608Medium dose powder for oral solution	Drug	BI 113608 medium dose 1
BI 113608Medium dose powder for oral solution	Drug	BI 113608 medium dose 2
BI 113608Low dose powder for oral solution	Drug	BI 113608 low dose 4

Primary outcome

Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, Lung Function, Carbon Monoxide Diffusing Capacity of the Lung, ECG, Physical Examination, Orthostasis Test, Oxygen Saturation or Haemoccult Test
Time frame: From administration of study drug until end-of-study visit, up to 10 days
Clinically relevant abnormalities for clinical laboratory evaluation, vital signs, lung function, carbon monoxide Diffusing Capacity Of the Lung (DLCO), Electrocardiogram (ECG), physical examination, orthostasis test, oxygen saturation or haemoccult test
Percentage of Participants With Drug-related Adverse Events
Time frame: From administration of study drug until end-of-study visit, up to 10 days
Percentage of participants with drug-related adverse events
Assessment of Tolerability by the Investigator
Time frame: End of study visit, up to day 10
Assessment of tolerability by the investigator assessed according to the categories good, satisfactory, not satisfactory, bad and not assessable.

5 secondary outcomes

Cmax
Time frame: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration
Tmax
Time frame: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration
AUC0-tz
Time frame: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration
AUC0-infinity
Time frame: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration
t1/2
Time frame: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration

Results and safety

Results posted to the registry on 20 Jan 2017, 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	20	20
BI 113608 0.5mg	6	6
BI 113608 1mg	6	6
BI 113608 2mg	6	6
BI 113608 5mg	6	6
BI 113608 10mg	6	6
BI 113608 20mg	6	6
BI 113608 50mg	6	6
BI 113608 100mg	6	6
BI 113608 150mg	6	6
BI 113608 200mg	6	6

Primary outcome: Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, Lung Function, Carbon Monoxide Diffusing Capacity of the Lung, ECG, Physical Examination, Orthostasis Test, Oxygen Saturation or Haemoccult Test

Time frame: From administration of study drug until end-of-study visit, up to 10 days. Number. Unit: Percentage of participants

Measure	Placebo n = 20	BI 113608 0.5mg n = 6	BI 113608 1mg n = 6	BI 113608 2mg n = 6	BI 113608 5mg n = 6	BI 113608 10mg n = 6	BI 113608 20mg n = 6	BI 113608 50mg n = 6	BI 113608 100mg n = 6	BI 113608 150mg n = 6	BI 113608 200mg n = 6
Value	0	0	0	0	0	0	0	0	0	0	0

Population analysed: Treated set

Primary outcome: Percentage of Participants With Drug-related Adverse Events

Time frame: From administration of study drug until end-of-study visit, up to 10 days. Number. Unit: Percentage of participants

Measure	Placebo n = 20	BI 113608 0.5mg n = 6	BI 113608 1mg n = 6	BI 113608 2mg n = 6	BI 113608 5mg n = 6	BI 113608 10mg n = 6	BI 113608 20mg n = 6	BI 113608 50mg n = 6	BI 113608 100mg n = 6	BI 113608 150mg n = 6	BI 113608 200mg n = 6
Value	0.0	33.3	0.0	0.0	0.0	0.0	0.0	0.0	50.0	0.0	33.3

Population analysed: Treated set

Primary outcome: Assessment of Tolerability by the Investigator

Time frame: End of study visit, up to day 10. Number. Unit: Percentage of participants

Measure	Placebo n = 20	BI 113608 0.5mg n = 6	BI 113608 1mg n = 6	BI 113608 2mg n = 6	BI 113608 5mg n = 6	BI 113608 10mg n = 6	BI 113608 20mg n = 6	BI 113608 50mg n = 6	BI 113608 100mg n = 6	BI 113608 150mg n = 6	BI 113608 200mg n = 6
Good	100	100	100	100	100	100	100	100	100	100	100
Satisfactory	0	0	0	0	0	0	0	0	0	0	0
Not satisfactory	0	0	0	0	0	0	0	0	0	0	0
Bad	0	0	0	0	0	0	0	0	0	0	0
Not assessable	0	0	0	0	0	0	0	0	0	0	0

Population analysed: Treated set

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From administration of study drug until end-of-study visit, up to 10 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 20 (0%)	2 of 20 (10%)	Not reported
BI 113608 0.5mg	0 of 6 (0%)	3 of 6 (50%)	Not reported
BI 113608 1mg	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
BI 113608 2mg	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
BI 113608 5mg	0 of 6 (0%)	0 of 6 (0%)	Not reported
BI 113608 10mg	1 of 6 (16.7%)	3 of 6 (50%)	Not reported
BI 113608 20mg	0 of 6 (0%)	0 of 6 (0%)	Not reported
BI 113608 50mg	0 of 6 (0%)	0 of 6 (0%)	Not reported
BI 113608 100mg	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
BI 113608 150mg	0 of 6 (0%)	0 of 6 (0%)	Not reported
BI 113608 200mg	0 of 6 (0%)	2 of 6 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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 113608 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 20 Jan 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 20 Jan 2017). 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?

Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, Lung Function, Carbon Monoxide Diffusing Capacity of the Lung, ECG, Physical Examination, Orthostasis Test, Oxygen Saturation or Haemoccult Test (time frame: From administration of study drug until end-of-study visit, up to 10 days). The study lists 3 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 NCT01540825.

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 20 Jan 2017.