HealthyPhase 1NCT01703858

Study to Investigate the Relative Bioavailability, Influence of Pantoprazole Coadministration and Food Effect of Different Oral Formulation of BI 113608

A Phase 1 study testing BI 113608 PIB, BI 113608 and pantoprazole 40 mg STADA 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 trial is to investigate the relative bioavailability, influence of pantoprazole coadministration and food effect of different oral formulations of BI 113608 in healthy male subjects 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, BI 113608 and pantoprazole 40 mg STADA
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteGermany
Study dates: Sep 2012to Jan 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

1314.3.1 Boehringer Ingelheim Investigational Site
Ingelheim

Other trials in Germany

About this study

Official title: An Open Label, Randomised, Single Dose, 3-way Cross Over Study to Investigate Relative Bioavailability and Food Effect on Different Formulations of BI 113608 in Healthy Male Subjects, Followed by Fixed Sequence Periods Investigating Influence of Pantoprazole Coadministration and Food Effect on Pharmacokinetics of Different Formulations of BI 113608

Conditions: Healthy
Being tested: BI 113608 PIB, BI 113608, pantoprazole 40 mg STADA

What participants receive

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

BI 113608 PIBDrug
powder for oral solution
BI 113608Drug
conventional tablet formulation
BI 113608Drug
conventional tablet formulation
BI 113608Drug
conventional tablet formulation
pantoprazole 40 mg STADADrug
film-coated tablet
BI 113608Drug
conventional tablet formulation

Study groups in NCT01703858
Study group	Role	What they receive
1 BI 113608	Active comparator	powder in the bottle for oral solution, oral administration with 240 mL water Receives: Drug: BI 113608 PIB
2 BI 113608	Experimental	conventional tablet formulation Receives: Drug: BI 113608
3 BI 113608	Experimental	conventional tablet formulation, fed Receives: Drug: BI 113608
4 BI 113608	Experimental	conventional tablet after pantoprazole administration Receives: Drug: pantoprazole 40 mg STADA; Drug: BI 113608
5 BI 113608	Experimental	conventional tablet formulation, fasted, 0:30 min before fat breakfast Receives: Drug: BI 113608

What is being measured

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

Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
Measured: PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.
Maximum Measured Concentration of the Analyte BI-113608 in Plasma (Cmax)
Maximum measured concentration of the analyte BI-113608 in plasma (Cmax).
Measured: PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.

Secondary outcomes (1)

Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)
Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity).
Measured: PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 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.

Sep 2012Jan 2013

First posted11 Oct 2012 (estimated)
Study startSep 2012
Primary completionJan 2013
Study completionJan 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: Crossover
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01703858
Sponsor's protocol ID: 1314.3
Other IDs: 2012-002537-11
Status last verified: Nov 2016
First submitted: 8 Oct 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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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: An Open Label, Randomised, Single Dose, 3-way Cross Over Study to Investigate Relative Bioavailability and Food Effect on Different Formulations of BI 113608 in Healthy Male Subjects, Followed by Fixed Sequence Periods Investigating Influence of Pantoprazole Coadministration and Food Effect on Pharmacokinetics of Different Formulations of BI 113608
ClinicalTrials.gov ID: NCT01703858
Acronym / sponsor ID: 1314.3
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Sep 2012
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 11 Oct 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
1 BI 113608	Active comparator	Drug: BI 113608 PIBpowder in the bottle for oral solution, oral administration with 240 mL water
2 BI 113608	Experimental	Drug: BI 113608conventional tablet formulation
3 BI 113608	Experimental	Drug: BI 113608conventional tablet formulation, fed
4 BI 113608	Experimental	Drug: pantoprazole 40 mg STADA, Drug: BI 113608conventional tablet after pantoprazole administration
5 BI 113608	Experimental	Drug: BI 113608conventional tablet formulation, fasted, 0:30 min before fat breakfast

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 PIBpowder for oral solution	Drug	1 BI 113608
BI 113608conventional tablet formulation	Drug	2 BI 113608
BI 113608conventional tablet formulation	Drug	3 BI 113608
BI 113608conventional tablet formulation	Drug	5 BI 113608
pantoprazole 40 mg STADAfilm-coated tablet	Drug	4 BI 113608
BI 113608conventional tablet formulation	Drug	4 BI 113608

Primary outcome

Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.
Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
Maximum Measured Concentration of the Analyte BI-113608 in Plasma (Cmax)
Time frame: PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.
Maximum measured concentration of the analyte BI-113608 in plasma (Cmax).

1 secondary outcome

Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)
Time frame: PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h 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
A - C - B - D - E	5	5
B - A - C - D - E	5	4
C - B - A - D - E	5	5

Primary outcome: Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

Time frame: PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.. Geometric mean (Geometric Coefficient of Variation). Unit: nanomol (nmol)* hours (h) / Litre (L)

Measure	A : BI-113608 n = 15	B : BI-113608 n = 15	C : BI-113608 n = 15	D : BI-113608 n = 15	E : BI-113608 n = 14
Value	936 (27.4)	924 (31.2)	648 (39.3)	900 (32.7)	759 (27.1)

A : BI-113608 vs B : BI-113608: Ratio of Geometric means (%): 98.68 (90% CI 92.501 to 105.272), p = 0.0000, ANOVA
B : BI-113608 vs C : BI-113608: Ratio of Geometric means (%): 70.16 (90% CI 62.331 to 78.962), p = 0.9644, ANOVA
B : BI-113608 vs E : BI-113608: Ratio of Geometric means (%): 83.36 (90% CI 73.648 to 94.346), p = 0.2835, ANOVA

Population analysed: Pharmacokinetic (PK) set: It included all treated subjects who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.

Primary outcome: Maximum Measured Concentration of the Analyte BI-113608 in Plasma (Cmax)

Measure	A : BI-113608 n = 15	B : BI-113608 n = 15	C : BI-113608 n = 15	D : BI-113608 n = 15	E : BI-113608 n = 14
Value	271 (44.6)	242 (47.5)	132 (77.8)	196 (50.0)	227 (53.1)

A : BI-113608 vs B : BI-113608: Ratio of Geometric means (%): 89.26 (90% CI 75.893 to 104.973), p = 0.1261, ANOVA
B : BI-113608 vs C : BI-113608: Ratio of Geometric means (%): 54.57 (90% CI 40.711 to 73.157), p = 0.9808, ANOVA
B : BI-113608 vs E : BI-113608: Ratio of Geometric means (%): 94.88 (90% CI 72.175 to 124.731), p = 0.1449, ANOVA

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From first drug administration until 14 days after the last drug administration, up to 42 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
A : BI-113608	0 of 15 (0%)	6 of 15 (40%)	Not reported
B : BI-113608	0 of 15 (0%)	6 of 15 (40%)	Not reported
C : BI-113608	0 of 15 (0%)	7 of 15 (46.7%)	Not reported
Pantoprazole 40mg	0 of 15 (0%)	3 of 15 (20%)	Not reported
D : BI-113608	0 of 15 (0%)	4 of 15 (26.7%)	Not reported
E : BI-113608	0 of 14 (0%)	5 of 14 (35.7%)	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 PIB, BI 113608 and pantoprazole 40 mg STADA 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?

Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (time frame: PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.). 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 NCT01703858.

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.