HealthyPhase 1NCT01787032

Drug-drug Interaction Trial of BI 113608 in Combination With Ketoconazole and Voriconazole in Healthy Male Subjects

A Phase 1 study testing BI 113608, Ketoconazole and Voriconazole 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

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, Ketoconazole and Voriconazole
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 2013to Apr 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
Ingelheim

Other trials in Germany

About this study

Official title: Relative Bioavailability of Single Oral Dose of BI 113608 When Administered Alone or in Combination With Multiple Oral Doses of Ketoconazole or Voriconazole in Healthy Male Subjects (an Open-label, Randomised, Three-period Cross-over Trial)

The primary objective of this trial is to investigate the relative bioavailability of a single oral dose of BI 113608 without and with ketoconazole and voriconazole at steady state. The assessment of safety and tolerability of BI 113608 administered alone and upon co-administration will be an additional objective of this trial.

Conditions: Healthy
Being tested: BI 113608, Ketoconazole, Voriconazole

What participants receive

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

BI 113608Drug
tablet
BI 113608Drug
tablet
BI 113608Drug
tablet
KetoconazoleDrug
tablet
VoriconazoleDrug
tablet

Study groups in NCT01787032
Study group	Role	What they receive
Period 3: BI 113608+Voriconazole	Experimental	tablets with 240 ml water Receives: Drug: BI 113608; Drug: Voriconazole
Period 2: BI 113608+Ketoconazole	Experimental	tablets with 240 ml water Receives: Drug: BI 113608; Drug: Ketoconazole
Period 1: BI 113608	Experimental	tablets with 240 ml water 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 BI 113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
This outcome measure presents the area under the concentration-time curve of BI 113608 in plasma over the time interval from 0 to the last quantifiable data point.
The parameter dispersion type (standard deviation) is actually intra individual geometric coefficient of variation (intraindividual gCV).
Statistical analysis 1: The ratio (Other) is calculated as BI+K (T1): BI (R) [%]. Statistical analysis 2: The ratio (Other) is calculated as BI + V (T2): BI (R) [%].
Measured: 1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.
Maximum Measured Concentration of BI 113608 in Plasma (Cmax)
This outcome measure presents the maximum measured concentration of BI 113608 in plasma.
The parameter dispersion type (standard deviation) is actually intra individual geometric coefficient of variation (intraindividual gCV).
Statistical analysis 1: The ratio (Other) is calculated as BI + K (T1): BI (R) [%]. Statistical analysis 2: The ratio (Other) is calculated as BI + V (T2): BI (R) [%].
Measured: 1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.

Secondary outcomes (3)

Area Under the Concentration-time Curve of BI 113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
This outcome measure presents area under the concentration-time curve of BI 113608 in plasma over the time interval from 0 to infinity.
The parameter dispersion type (standard deviation) is actually intra individual geometric coefficient of variation (intraindividual gCV).
Statistical analysis 1: The ratio (Other) is calculated as BI + K (T1): BI (R) [%]. Statistical analysis 2: The ratio (Other) is calculated as BI + V (T2): BI (R) [%].
Measured: 1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.
Time From Dosing to Maximum Measured Concentration of BI 113608 in Plasma (Tmax)
This outcome measure presents time from dosing to maximum measured concentration of BI 113608 in plasma.
Measured: 1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.
Terminal Half-life of BI 113608 in Plasma (t1/2)
This outcome measure presents terminal half-life of BI 113608 in plasma.
Measured: 1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.

Timeline

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

Jan 2013Apr 2013

First posted8 Feb 2013 (estimated)
Study startJan 2013
Primary completionApr 2013
Study completionApr 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: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01787032
Sponsor's protocol ID: 1314.7
Other IDs: 2012-002538-36
Status last verified: Jan 2017
First submitted: 30 Jan 2013
Last updated: 15 Mar 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?

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Study at a glance

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

Official title: Relative Bioavailability of Single Oral Dose of BI 113608 When Administered Alone or in Combination With Multiple Oral Doses of Ketoconazole or Voriconazole in Healthy Male Subjects (an Open-label, Randomised, Three-period Cross-over Trial)
ClinicalTrials.gov ID: NCT01787032
Acronym / sponsor ID: 1314.7
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 2013
Primary completion: Apr 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 8 Feb 2013 (estimated)
Results: Posted 15 Mar 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: 3

Arm	Type	Receives
Period 3: BI 113608+Voriconazole	Experimental	Drug: BI 113608, Drug: Voriconazoletablets with 240 ml water
Period 2: BI 113608+Ketoconazole	Experimental	Drug: BI 113608, Drug: Ketoconazoletablets with 240 ml water
Period 1: BI 113608	Experimental	Drug: BI 113608tablets 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 113608tablet	Drug	Period 3: BI 113608+Voriconazole
BI 113608tablet	Drug	Period 2: BI 113608+Ketoconazole
BI 113608tablet	Drug	Period 1: BI 113608
Ketoconazoletablet	Drug	Period 2: BI 113608+Ketoconazole
Voriconazoletablet	Drug	Period 3: BI 113608+Voriconazole

Primary outcome

Area Under the Concentration-time Curve of BI 113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: 1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.
This outcome measure presents the area under the concentration-time curve of BI 113608 in plasma over the time interval from 0 to the last quantifiable data point. The parameter dispersion type (standard deviation) is actually intra individual geometric coefficient of variation (intraindividual gCV). Statistical analysis 1: The ratio (Other) is calculated as BI+K (T1): BI (R) [%]. Statistical analysis 2: The ratio (Other) is calculated as BI + V (T2): BI (R) [%].
Maximum Measured Concentration of BI 113608 in Plasma (Cmax)
Time frame: 1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.
This outcome measure presents the maximum measured concentration of BI 113608 in plasma. The parameter dispersion type (standard deviation) is actually intra individual geometric coefficient of variation (intraindividual gCV). Statistical analysis 1: The ratio (Other) is calculated as BI + K (T1): BI (R) [%]. Statistical analysis 2: The ratio (Other) is calculated as BI + V (T2): BI (R) [%].

3 secondary outcomes

Area Under the Concentration-time Curve of BI 113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: 1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.
Time From Dosing to Maximum Measured Concentration of BI 113608 in Plasma (Tmax)
Time frame: 1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.
Terminal Half-life of BI 113608 in Plasma (t1/2)
Time frame: 1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.

Results and safety

Results posted to the registry on 15 Mar 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
BI 113608/BI 113608 + Ketoconazole/BI 113608 + Voriconazole	3	3
BI 113608/BI 113608 + Voriconazole/ BI 113608 + Ketoconazole	3	3
BI 113608 + Ketoconazole/ BI 113608/ BI 113608 + Voriconazole	3	3
BI 113608 + Ketoconazole/ BI 113608 + Voriconazole/ BI 113608	3	3
BI 113608 + Voriconazole/ BI 113608/ BI 113608 + Ketoconazole	4	3
BI 113608 + Voriconazole/ BI 113608 + Ketoconazole/ BI 113608	4	3

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

Time frame: 1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.. Geometric mean (Geometric Coefficient of Variation). Unit: nanomol*hours/litre (nmol*h/L)

Measure	BI 113608 n = 18	BI 113608 + Ketoconazole n = 18	BI 113608 + Voriconazole n = 18
Value	494 (36.7)	1840 (36.9)	1320 (51.4)

BI 113608 vs BI 113608 + Ketoconazole: Ratio: 373.66 (90% CI 346.029 to 403.507), ANOVA
BI 113608 vs BI 113608 + Voriconazole: Ratio: 266.94 (90% CI 243.267 to 292.914), ANOVA

Population analysed: Pharmacokinetic Set (PKS): The 'PK set' included all subjects of the treated set who provided at least one evaluable observation for at least one primary PK endpoint in at least one treatment period without important protocol violations relevant to the evaluation of PK; PK analyses were based on the PK set.

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

Measure	BI 113608 n = 18	BI 113608 + Ketoconazole n = 18	BI 113608 + Voriconazole n = 18
Value	102 (55.5)	267 (41.9)	218 (54)

BI 113608 vs BI 113608 + Ketoconazole: Ratio: 261.34 (90% CI 211.692 to 322.633), ANOVA
BI 113608 vs BI 113608 + Voriconazole: Ratio: 213.39 (90% CI 175.783 to 259.051), ANOVA

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 15 days of treatment (including two 6-days-wash-out periods between BI 113608 treatments) followed by up to 12 days until the end of study. After study completion there was 30 days Adverse Event (AE) follow up period. 57 days on total.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BI 113608	0 of 18 (0%)	3 of 18 (16.7%)	Not reported
BI 113608 + Ketoconazole	0 of 18 (0%)	3 of 18 (16.7%)	Not reported
BI 113608 + Voriconazole	0 of 19 (0%)	5 of 19 (26.3%)	Not reported
Ketoconazole	0 of 19 (0%)	9 of 19 (47.4%)	Not reported
Voriconazole	0 of 20 (0%)	12 of 20 (60%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 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, Ketoconazole and Voriconazole 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 Mar 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 15 Mar 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 BI 113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (time frame: 1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours 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 NCT01787032.

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 Mar 2017.