HealthyPhase 1NCT02044393

Interaction of BI 691751 With Itraconazole

A Phase 1 study testing itraconazole and BI 691751 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

Investigation of the relative bioavailability of a single dose of BI 691751 when given alone and together with itraconazole; safety and tolerability 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?: itraconazole and BI 691751
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteGermany
Study dates: Jan 2014to May 2014
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

Healthy male subjects
body mass index (BMI) of 18.5 to 29.9 kg/m2
Subjects must be able to understand and comply with study requirements

Who cannot join

Any finding in the medical examination (including blood pressure (BP), pulse rate (PR), or electrocardiogram (ECG)) deviating from normal and judged clinically relevant by the investigator.
Pulse rate outside 45 to 100 bpm or repeated measurements of systolic BP outside 90 to 140 mmHg or diastolic BP outside 50 to 90 mmHg.
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any alanine transaminase (ALT/GPT), aspartate transaminase (AST/GOT), or gammaglutamyltransferase (GGT) value outside the reference range at the screening examination
Any evidence of a concomitant disease judged clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
Any history of relevant liver diseases such as disturbance of liver function, jaundice, drug induced liver injury, Dubin-Johnson syndrome, Rotor syndrome, or liver tumors

Trial locations and contacts

1 site in 1 country.

Germany1 site

1334.10.1 Boehringer Ingelheim Investigational Site
Biberach

Other trials in Germany

About this study

Official title: Relative Bioavailability of a Single Oral Dose of BI 691751 When Administered Alone or in Combination With Multiple Oral Doses of Itraconazole in Healthy Male Subjects (an Open-label, Randomised, Two-period, Two-sequence Crossover Study)

Investigation of the relative bioavailability of a single dose of BI 691751 when given alone and together with itraconazole; safety and tolerability

Conditions: Healthy
Being tested: itraconazole, BI 691751

What participants receive

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

itraconazoleDrug
multiple doses of itraconazole given as capsules
BI 691751Drug
single dose BI 691751 given as tablet
BI 691751Drug
single dose BI 691751 given as tablet

Study groups in NCT02044393
Study group	Role	What they receive
Reference	Experimental	single dose BI 691751 Receives: Drug: BI 691751
Test	Experimental	multiple doses of itraconazole + single dose BI 691751 Receives: Drug: itraconazole; Drug: BI 691751

What is being measured

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

AUC0-tz (Area Under the Concentration-time Curve of BI 691751 in Plasma and Whole Blood Over the Time Interval From 0 up to the Last Quantifiable Concentration)
AUC0-tz: area under the concentration-time curve of BI 691751 in plasma and whole blood over the time interval from 0 up to the last quantifiable concentration.
Measured: from day 1 to 31 days postdose relative to BI 691751 administration (h:min): -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.
Cmax (Maximum Measured Concentration of BI 691751 in Plasma and Whole Blood)
Cmax (maximum measured concentration of BI 691751 in plasma and whole blood).
Measured: From day 1 to 31 days postdose relative to BI 691751 administration (h:min): -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.

Secondary outcomes (1)

AUC0-infinity (Area Under the Concentration-time Curve of BI 691751 in Plasma and Whole Blood Over the Time Interval From 0 Extrapolated to Infinity)
AUC0-infinity (area under the concentration-time curve of BI 691751 in plasma and whole blood over the time interval from 0 extrapolated to infinity).
Measured: from day 1 to 31 days postdose relative to BI 691751 administration time: -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.

Timeline

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

Jan 2014May 2014

First posted24 Jan 2014 (estimated)
Study startJan 2014
Primary completionMay 2014
Study completionMay 2014

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: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02044393
Sponsor's protocol ID: 1334.10
Other IDs: 2013-003814-42
Status last verified: Nov 2015
First submitted: 22 Jan 2014
Last updated: 16 Dec 2015
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 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of a Single Oral Dose of BI 691751 When Administered Alone or in Combination With Multiple Oral Doses of Itraconazole in Healthy Male Subjects (an Open-label, Randomised, Two-period, Two-sequence Crossover Study)
ClinicalTrials.gov ID: NCT02044393
Acronym / sponsor ID: 1334.10
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jan 2014
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 24 Jan 2014 (estimated)
Results: Posted 16 Dec 2015

Clinical summary

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

Investigation of the relative bioavailability of a single dose of BI 691751 when given alone and together with itraconazole; safety and tolerability

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Reference	Experimental	Drug: BI 691751single dose BI 691751
Test	Experimental	Drug: itraconazole, Drug: BI 691751multiple doses of itraconazole + single dose BI 691751

Who may qualify

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

Key inclusion criteria (3 listed)

Healthy male subjects
body mass index (BMI) of 18.5 to 29.9 kg/m2
Subjects must be able to understand and comply with study requirements

Key exclusion criteria (7 listed)

Any finding in the medical examination (including blood pressure (BP), pulse rate (PR), or electrocardiogram (ECG)) deviating from normal and judged clinically relevant by the investigator.
Pulse rate outside 45 to 100 bpm or repeated measurements of systolic BP outside 90 to 140 mmHg or diastolic BP outside 50 to 90 mmHg.
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any alanine transaminase (ALT/GPT), aspartate transaminase (AST/GOT), or gammaglutamyltransferase (GGT) value outside the reference range at the screening examination
Any evidence of a concomitant disease judged clinically relevant by the investigator

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
itraconazolemultiple doses of itraconazole given as capsules	Drug	Test
BI 691751single dose BI 691751 given as tablet	Drug	Test
BI 691751single dose BI 691751 given as tablet	Drug	Reference

Primary outcome

AUC0-tz (Area Under the Concentration-time Curve of BI 691751 in Plasma and Whole Blood Over the Time Interval From 0 up to the Last Quantifiable Concentration)
Time frame: from day 1 to 31 days postdose relative to BI 691751 administration (h:min): -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.
AUC0-tz: area under the concentration-time curve of BI 691751 in plasma and whole blood over the time interval from 0 up to the last quantifiable concentration.
Cmax (Maximum Measured Concentration of BI 691751 in Plasma and Whole Blood)
Time frame: From day 1 to 31 days postdose relative to BI 691751 administration (h:min): -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.
Cmax (maximum measured concentration of BI 691751 in plasma and whole blood).

1 secondary outcome

AUC0-infinity (Area Under the Concentration-time Curve of BI 691751 in Plasma and Whole Blood Over the Time Interval From 0 Extrapolated to Infinity)
Time frame: from day 1 to 31 days postdose relative to BI 691751 administration time: -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.

Results and safety

Results posted to the registry on 16 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Itraconazole (IT) +BI 691751 / BI 691751	10	10
BI 691751 / IT+BI 691751	10	10

Primary outcome: AUC0-tz (Area Under the Concentration-time Curve of BI 691751 in Plasma and Whole Blood Over the Time Interval From 0 up to the Last Quantifiable Concentration)

Time frame: from day 1 to 31 days postdose relative to BI 691751 administration (h:min): -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.. Geometric mean (Geometric Coefficient of Variation). Unit: nmol*h/L

Measure	BI 691751 n = 20	IT + BI 691751 n = 20
in plasma	2830 (34.6)	2090 (43.2)
in whole blood	25000 (25.8)	21600 (25.8)

BI 691751 vs IT + BI 691751: gMean ratio: 74.07 (90% CI 62.371 to 87.959)
BI 691751 vs IT + BI 691751: gMean ratio: 86.35 (90% CI 78.04 to 95.56)

Population analysed: Pharmacokinetic Set (PKS): included all subjects from the TS who provided at least one primary or secondary pharmacokinetic endpoint in any period that is judged as evaluable for pharmacokinetics and is not affected by protocol violations relevant to the statistical evaluation of bioavailability

Primary outcome: Cmax (Maximum Measured Concentration of BI 691751 in Plasma and Whole Blood)

Time frame: From day 1 to 31 days postdose relative to BI 691751 administration (h:min): -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.. Geometric mean (Geometric Coefficient of Variation). Unit: nmol/L

Measure	BI 691751 n = 20	IT + BI 691751 n = 20
in plasma	157 (24.4)	150 (34.1)
in whole blood	217 (16.0)	203 (21.4)

BI 691751 vs IT + BI 691751: gMean ratio: 95.59 (90% CI 84.195 to 108.537)
BI 691751 vs IT + BI 691751: gMean ratio: 93.54 (90% CI 86.142 to 101.570)

Population analysed: PKS

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From the 1st trial drug administration of a treatment until the 1st trial drug intake in the next treatment or until 31 days after the last administration of BI were assigned to the respective on-treatment phases (BI alone, loading IT, BI + further IT). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BI 691751	0 of 20 (0%)	0 of 20 (0%)	Not reported
Loading Itraconazole (IT)	0 of 20 (0%)	0 of 20 (0%)	Not reported
BI 691751 + Further IT	0 of 20 (0%)	0 of 20 (0%)	Not reported
Total BI 691751	0 of 20 (0%)	0 of 20 (0%)	Not reported
Total on Treatment	0 of 20 (0%)	0 of 20 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
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 itraconazole and BI 691751 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 3 inclusion and 7 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 16 Dec 2015. 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 16 Dec 2015). 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?

AUC0-tz (Area Under the Concentration-time Curve of BI 691751 in Plasma and Whole Blood Over the Time Interval From 0 up to the Last Quantifiable Concentration) (time frame: from day 1 to 31 days postdose relative to BI 691751 administration (h:min): -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.). 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 NCT02044393.

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 16 Dec 2015; AzTrials last refreshed its copy on 7 Nov 2026.