HealthyPhase 1NCT01681277

Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 in Healthy Male Volunteers

A Phase 1 study testing BI 113608 PIB bid and BI 113608 PIB qd 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.

Official record

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Trial summary

The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of multiple rising doses of BI 113608 in healthy male volunteers 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 PIB bid and BI 113608 PIB qd
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 1 siteGermany
Study dates: Sep 2012to May 2013
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 Multiple Rising Doses of BI 113608 Powder for Oral Solution in Healthy Male Volunteers q.d. or b.i.d. for 14 Days (a Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Trial)

The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of multiple rising doses of BI 113608 in healthy male volunteers

Conditions: Healthy
Being tested: BI 113608 PIB bid, Placebo to BI 113608 PIB bid, Placebo to BI 113608 PIB qd, BI 113608 PIB qd

What participants receive

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

BI 113608 PIB bidDrug
powder for oral solution
Placebo to BI 113608 PIB bidDrug
powder for oral solution
Placebo to BI 113608 PIB bidDrug
powder for oral solution
Placebo to BI 113608 PIB qdDrug
powder for oral solution
Placebo to BI 113608 PIB bidDrug
powder for oral solution
BI 113608 PIB bidDrug
powder for oral solution
BI 113608 PIB bidDrug
powder for oral solution
BI 113608 PIB qdDrug
powder for oral solution

Study groups in NCT01681277
Study group	Role	What they receive
BI 113608 high dose bid	Experimental	powder in the bottle for oral solution, oral administration with 240 ml water Receives: Drug: Placebo to BI 113608 PIB bid; Drug: BI 113608 PIB bid
BI 113608 low dose bid	Experimental	powder in the bottle for oral solution, oral administration with 240 ml water Receives: Drug: Placebo to BI 113608 PIB bid; Drug: BI 113608 PIB bid
BI 113608 medium dose bid	Experimental	powder in the bottle for oral solution, oral administration with 240 ml water Receives: Drug: BI 113608 PIB bid; Drug: Placebo to BI 113608 PIB bid
BI 113608 high dose qd	Experimental	powder in the bottle for oral solution, oral administration with 240 ml water Receives: Drug: Placebo to BI 113608 PIB qd; Drug: BI 113608 PIB qd

What is being measured

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

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, up to 17 days
Number of Participants With Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, and ECG Recordings
Number of participants with Clinically relevant abnormalities for clinical laboratory tests (haematology, clinical chemistry and urinalysis), vital signs (blood pressure (BP), pulse rate (PR), respiratory rate (RR), body temperature), and 12- lead electrocardiogram (ECG)
Measured: From administration of study drug until end-of-study, up to 17 days

Secondary outcomes (6)

Cmax,ss
Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss).
Measured: 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.
Tmax,ss
Time from last dosing to maximum concentration of the analyte in plasma at steady state (tmax,ss).
Measured: 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.
AUCtau,ss
Area under the concentration-time curve of the analyte BI 113608 in plasma at steady state over a uniform dosing interval t (AUCtau,ss).
Measured: 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.
t1/2,ss
Terminal half-life of the analyte in plasma at steady state (t1/2,ss).
Measured: 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 360h, 384h after last dose.
RA,Cmax
Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval t, expressed as ratio of Cmax at steady state and after single dose (RA,Cmax).
Measured: -2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose.
RA,AUC
Accumulation ratio of the analyte in plasma at steady state after multiple dose administration over a uniform dosing interval t, expressed as ratio of AUC at steady state and after single dose (RA,AUC).
Measured: -2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose.

Timeline

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

Sep 2012May 2013

First posted7 Sep 2012 (estimated)
Study startSep 2012
Primary completionMay 2013
Study completionMay 2013

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: Double blind
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01681277
Sponsor's protocol ID: 1314.2
Other IDs: 2012-002536-82
Status last verified: Nov 2016
First submitted: 5 Sep 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 Multiple Rising Doses of BI 113608 Powder for Oral Solution in Healthy Male Volunteers q.d. or b.i.d. for 14 Days (a Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Trial)
ClinicalTrials.gov ID: NCT01681277
Acronym / sponsor ID: 1314.2
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Sep 2012
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 7 Sep 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 objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of multiple rising doses of BI 113608 in healthy male volunteers

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind
Number of arms: 4

Arm	Type	Receives
BI 113608 high dose bid	Experimental	Drug: Placebo to BI 113608 PIB bid, Drug: BI 113608 PIB bidpowder in the bottle for oral solution, oral administration with 240 ml water
BI 113608 low dose bid	Experimental	Drug: Placebo to BI 113608 PIB bid, Drug: BI 113608 PIB bidpowder in the bottle for oral solution, oral administration with 240 ml water
BI 113608 medium dose bid	Experimental	Drug: BI 113608 PIB bid, Drug: Placebo to BI 113608 PIB bidpowder in the bottle for oral solution, oral administration with 240 ml water
BI 113608 high dose qd	Experimental	Drug: Placebo to BI 113608 PIB qd, Drug: BI 113608 PIB qdpowder in the bottle for oral solution, oral administration with 240 ml water

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 113608 PIB bidpowder for oral solution	Drug	BI 113608 medium dose bid
Placebo to BI 113608 PIB bidpowder for oral solution	Drug	BI 113608 low dose bid
Placebo to BI 113608 PIB bidpowder for oral solution	Drug	BI 113608 medium dose bid
Placebo to BI 113608 PIB qdpowder for oral solution	Drug	BI 113608 high dose qd
Placebo to BI 113608 PIB bidpowder for oral solution	Drug	BI 113608 high dose bid
BI 113608 PIB bidpowder for oral solution	Drug	BI 113608 high dose bid
BI 113608 PIB bidpowder for oral solution	Drug	BI 113608 low dose bid
BI 113608 PIB qdpowder for oral solution	Drug	BI 113608 high dose qd

Primary outcome

Percentage of Participants With Drug-related Adverse Events
Time frame: From administration of study drug until end-of-study, up to 17 days
Percentage of participants with drug-related adverse events
Number of Participants With Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, and ECG Recordings
Time frame: From administration of study drug until end-of-study, up to 17 days
Number of participants with Clinically relevant abnormalities for clinical laboratory tests (haematology, clinical chemistry and urinalysis), vital signs (blood pressure (BP), pulse rate (PR), respiratory rate (RR), body temperature), and 12- lead electrocardiogram (ECG)

6 secondary outcomes

Cmax,ss
Time frame: 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.
Tmax,ss
Time frame: 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.
AUCtau,ss
Time frame: 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.
t1/2,ss
Time frame: 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 360h, 384h after last dose.
RA,Cmax
Time frame: -2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose.
RA,AUC
Time frame: -2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose.

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	12	11
BI 113608 25 mg Bid (DG1)	9	9
BI 113608 50 mg Bid (DG2)	9	9
BI 113608 100 mg Bid (DG3)	9	9
BI 113608 100 mg qd (DG4)	9	9

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

Time frame: From administration of study drug until end-of-study, up to 17 days. Number. Unit: percentage of participants

Measure	Placebo n = 12	BI 113608 25 mg Bid (DG1) n = 9	BI 113608 50 mg Bid (DG2) n = 9	BI 113608 100 mg Bid (DG3) n = 9	BI 113608 100 mg qd (DG4) n = 9
Value	33.3	33.3	22.2	88.9	77.8

Population analysed: Treated set

Primary outcome: Number of Participants With Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, and ECG Recordings

Time frame: From administration of study drug until end-of-study, up to 17 days. Number. Unit: participants

Measure	Placebo n = 12	BI 113608 25 mg Bid (DG1) n = 9	BI 113608 50 mg Bid (DG2) n = 9	BI 113608 100 mg Bid (DG3) n = 9	BI 113608 100 mg qd (DG4) n = 9
Value	0	0	0	0	0

Population analysed: Treated Set (TS)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From administration of study drug until end-of-study, up to 17 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 12 (0%)	5 of 12 (41.7%)	Not reported
BI 113608 25 mg Bid (DG1)	0 of 9 (0%)	4 of 9 (44.4%)	Not reported
BI 113608 50 mg Bid (DG2)	0 of 9 (0%)	2 of 9 (22.2%)	Not reported
BI 113608 100 mg Bid (DG3)	0 of 9 (0%)	8 of 9 (88.9%)	Not reported
BI 113608 100 mg qd (DG4)	0 of 9 (0%)	7 of 9 (77.8%)	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.

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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 PIB bid and BI 113608 PIB qd 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. 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?

Percentage of Participants With Drug-related Adverse Events (time frame: From administration of study drug until end-of-study, up to 17 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 NCT01681277.

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.