HealthyPhase 1NCT01153724

Relative Bioavailability of Olodaterol and Fluconazole

A Phase 1 study testing BI 1744 and Fluconazole in people with Healthy and Pulmonary Disease, Chronic Obstructive, 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

This clinical trial is intended to investigate a possible effect of the CYP 2C9 inhibitor fluconazole on the bioavailability of olodaterol Read more about this study

Who is it for?: Ages 21 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy, Pulmonary Disease, Chronic Obstructive
What is being tested?: BI 1744 and Fluconazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteGermany
Study dates: May 2010to Jul 2010
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 21 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male and female volunteers

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Germany1 site

1222.48.1 Boehringer Ingelheim Investigational Site
Berlin

Other trials in Germany

About this study

Official title: Relative Bioavailability of 10 mcg Olodaterol (Solution for Inhalation Administered With the Respimat) at Steady State Alone or in Combination With Multiple Doses of 400 mg q.d. Fluconazole (Hard Capsule) in Healthy Male and Female Volunteers (an Open Label, Fixed Sequence, Phase I Study)

This clinical trial is intended to investigate a possible effect of the CYP 2C9 inhibitor fluconazole on the bioavailability of olodaterol

Conditions: Healthy, Pulmonary Disease, Chronic Obstructive
Being tested: BI 1744, Fluconazole
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

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

BI 1744Drug
10 mcg solution for oral inhalation
FluconazoleDrug
400 mg capsule

Study groups in NCT01153724
Study group	Role	What they receive
Olodaterol	Experimental	Not described Receives: Drug: BI 1744
Olodaterol + Fluconazole	Experimental	Not described Receives: Drug: BI 1744; Drug: Fluconazole

What is being measured

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

Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss)
AUC0-6,ss represents the area under the concentration curve of olodaterol in plasma from 0 to time t=6 hours at steady state, where t is defined as the latest time-point where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of olodaterol. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.
Measured: Day 8 of period 1 and day 14 of period 2
Maximum Concentration at Steady State (Cmax,ss)
Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.
Measured: Day 8 of period 1 and day 14 of period 2

Secondary outcomes (6)

Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)
tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state.
Measured: Day 8 of period 1 and day 14 of period 2
Fraction of Urine Excretion From 0 to 24 Hours at Steady State (fe0-24,ss)
fe0-24,ss represents the fraction of olodaterol eliminated in urine from time point 0 to 24 hours after administration at steady state.
Measured: Day 8 of period 1 and day 14 of period 2
Amount of the Analyte Excreted in Urine From 0 to 24 Hours at Steady State (Ae0-24,ss)
Ae0-24,ss represents the amount of olodaterol and olodaterol glucuronide excreted in urine from 0 to time t=24 at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.
Measured: Day 8 of period 1 and day 14 of period 2
Area Under Curve From 0 to 12 Hours at Steady State (AUC0-12,ss)
AUC0-12,ss represents the area under the concentration curve of olodaterol glucuronide in plasma from 0 to time t=12 at steady state, where t is defined as the latest timepoint where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of the analyte. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.
Measured: Day 8 of period 1 and day 14 of period 2
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
Measured: First administration of trial medication until 6 days after last administration of trial medication
Assessment of Tolerability by the Investigator
The investigator assessed tolerability based on adverse events and the laboratory evaluation at the end-of-trial examination. The investigator classified the overall tolerability according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'.
Measured: End of period 1 and end of period 2

Timeline

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

May 2010Jul 2010

First posted30 Jun 2010 (estimated)
Study startMay 2010
Primary completionJul 2010

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01153724
Sponsor's protocol ID: 1222.48
Other IDs: 2010-018528-18
Status last verified: May 2014
First submitted: 29 Jun 2010
Last updated: 10 Jun 2014
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 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of 10 mcg Olodaterol (Solution for Inhalation Administered With the Respimat) at Steady State Alone or in Combination With Multiple Doses of 400 mg q.d. Fluconazole (Hard Capsule) in Healthy Male and Female Volunteers (an Open Label, Fixed Sequence, Phase I Study)
ClinicalTrials.gov ID: NCT01153724
Acronym / sponsor ID: 1222.48
Conditions: Healthy, Pulmonary Disease, Chronic Obstructive
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: May 2010
Primary completion: Jul 2010 (actual)
First posted: 30 Jun 2010 (estimated)
Results: Posted 10 Jun 2014

Clinical summary

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

This clinical trial is intended to investigate a possible effect of the CYP 2C9 inhibitor fluconazole on the bioavailability of olodaterol

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Olodaterol	Experimental	Drug: BI 1744
Olodaterol + Fluconazole	Experimental	Drug: BI 1744, Drug: Fluconazole

Who may qualify

Ages: 21 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy male and female volunteers

Key exclusion criteria (0 listed)

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 174410 mcg solution for oral inhalation	Drug	Olodaterol, Olodaterol + Fluconazole
Fluconazole400 mg capsule	Drug	Olodaterol + Fluconazole

Primary outcome

Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss)
Time frame: Day 8 of period 1 and day 14 of period 2
AUC0-6,ss represents the area under the concentration curve of olodaterol in plasma from 0 to time t=6 hours at steady state, where t is defined as the latest time-point where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of olodaterol. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.
Maximum Concentration at Steady State (Cmax,ss)
Time frame: Day 8 of period 1 and day 14 of period 2
Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.

6 secondary outcomes

Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)
Time frame: Day 8 of period 1 and day 14 of period 2
Fraction of Urine Excretion From 0 to 24 Hours at Steady State (fe0-24,ss)
Time frame: Day 8 of period 1 and day 14 of period 2
Amount of the Analyte Excreted in Urine From 0 to 24 Hours at Steady State (Ae0-24,ss)
Time frame: Day 8 of period 1 and day 14 of period 2
Area Under Curve From 0 to 12 Hours at Steady State (AUC0-12,ss)
Time frame: Day 8 of period 1 and day 14 of period 2
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
Time frame: First administration of trial medication until 6 days after last administration of trial medication
Assessment of Tolerability by the Investigator
Time frame: End of period 1 and end of period 2

Results and safety

Results posted to the registry on 10 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Study	35	34

Primary outcome: Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss)

Time frame: Day 8 of period 1 and day 14 of period 2. Geometric mean (Geometric Coefficient of Variation). Unit: Picogram*hours/milliliter

Measure	Olodaterol n = 24	Olodaterol Plus Fluconazole n = 28
Value	19.659 (13.6)	22.271 (13.6)

Olodaterol vs Olodaterol Plus Fluconazole: Adjusted geometric mean ratio: 113.29 (90% CI 105.893 to 121.197), p = 0.0101, ANOVA

Population analysed: Pharmacokinetic (PK) analysis set includes all evaluable subjects in the treated set providing at least 1 observation for at least 1 PK endpoint without important protocol violations.

Primary outcome: Maximum Concentration at Steady State (Cmax,ss)

Time frame: Day 8 of period 1 and day 14 of period 2. Geometric mean (Geometric Coefficient of Variation). Unit: Picogram/milliliter

Measure	Olodaterol n = 33	Olodaterol Plus Fluconazole n = 32
Olodaterol (N=30;32)	5.336 (15.5)	5.805 (15.5)
Olodaterol glucuronide (N=33;32)	4.211 (19.4)	3.621 (19.4)

Olodaterol vs Olodaterol Plus Fluconazole: Adjusted geometric mean ratio: 108.78 (90% CI 101.590 to 116.487), p = 0.0009, ANOVA
Olodaterol vs Olodaterol Plus Fluconazole: Adjusted geometric mean: 85.98 (90% CI 79.277 to 93.253), p = 0.0711, ANOVA

Population analysed: PK analysis set

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: First administration of trial medication until 6 days after last administration of trial medication. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Olodaterol	0 of 35 (0%)	2 of 35 (5.7%)	Not reported
Olodaterol Plus Fluconazole	0 of 34 (0%)	18 of 34 (52.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2014.
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 1744 and Fluconazole in people with Healthy and Pulmonary Disease, Chronic Obstructive, 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 0 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 10 Jun 2014. 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 10 Jun 2014). 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 Curve From 0 to 6 Hours at Steady State (AUC0-6,ss) (time frame: Day 8 of period 1 and day 14 of period 2). 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 NCT01153724.

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 10 Jun 2014.