HealthyPhase 1NCT02635750

Investigation of Pharmacokinetic Drug-drug Interaction of BI 409306 and Donepezil in Healthy Male and Female Subjects

A Phase 1 study testing BI 409306 and Donepezil 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

Part I: To investigate whether and to what extent donepezil affects single dose pharmacokinetics of BI 409306 Part II: To investigate whether and to what extent BI 409306 affects the single dose pharmacokinetics of donepezil Read more about this study

Who is it for?: Ages 15 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 409306 and Donepezil
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteGermany
Study dates: 15 Jan 2016to 4 Apr 2016
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 15 to 55 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Healthy male/female subjects,
age of 18 to 55 years,
body mass index (BMI) of 18.5 to 29.9 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Male subjects, or female subjects who meet any of the following criteria starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion:
Use of adequate contraception, e.g. any of the following methods plus condom:

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intrauterine device (non-hormonal)
Sexually abstinent
A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
Surgically sterilised (including hysterectomy)
Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)

Who cannot join

Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 60 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and simple hernia repair)

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Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
History of relevant orthostatic hypotension, fainting spells, or blackouts
Chronic or relevant acute infections
History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
Intake of drugs with a long half-life (more than 24 h) within 30 days or less than 10 half-lives of the respective drug prior to administration of trial medication
Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial or that might prolong the QT/QTc interval
Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication
Smoker
Alcohol abuse Further exclusion criteria apply

Trial locations and contacts

1 site in 1 country.

Germany1 site

CRS Clinical Research Services Mannheim GmbH
Mannheim, 68167

Other trials in Germany

About this study

Official title: A Study to Investigate the Pharmacokinetic Drug-drug Interaction Following Oral Administration of BI 409306 and Donepezil in Healthy Male and Female Subjects

Part I:

To investigate whether and to what extent donepezil affects single dose pharmacokinetics of BI 409306

Part II:

To investigate whether and to what extent BI 409306 affects the single dose pharmacokinetics of donepezil

Conditions: Healthy
Being tested: BI 409306, Donepezil

What participants receive

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

BI 409306Drug
DonepezilDrug

Study groups in NCT02635750
Study group	Role	What they receive
Part 1: 25 mg BI 409306 (R1) / 25 mg BI 409306 + 10 mg donepezil (T1)	Experimental	Subjects received treatment in a fixed sequence. First BI 409306 as reference treatment (R1)), then BI 409306 + donepezil as test treatment (T1)). Receives: Drug: BI 409306; Drug: Donepezil
Part 2: 5 mg donepezil (R2) / 5 mg donepezil + 100 mg BI 409306 (T2)	Experimental	Subjects received first the reference treatment (R2) followed by a washout period, followed by the test treatment (T2). Receives: Drug: BI 409306; Drug: Donepezil
Part 2: 5 mg donepezil + 100 mg BI 409306 (T2) / 5 mg donepezil (R2)	Experimental	Subjects received first the test treatment 2 (T2) followed by a washout period, followed by the reference treatment 2 (R2)). Receives: Drug: BI 409306; Drug: Donepezil

What is being measured

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

Part 1: AUC0-tz of BI 409306
Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 to the last quantifiable data point.
Measured: Within 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours thereafter.
Part 1: Cmax of BI 409306
Maximum measured concentration of the BI 409306 in plasma.
Measured: Within 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14,16 hours thereafter.
Part 2: AUC0-tz of Donepezil
Area under the concentration-time curve of donepezil in plasma over the time interval from 0 to the last quantifiable data point.
Measured: At approximate 2 hours (h) prior to first administration of donepezil and 1, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 15, 24:30, 48:30, 72:30, 96:30, 120:30, 144:30, 168:30 hours thereafter.
Part 2: Cmax of Donepezil
Maximum measured concentration of the donepezil in plasma.
Measured: At approximate 2 hours (h) prior to first administration of donepezil and 1, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 15, 24:30, 48:30, 72:30, 96:30, 120:30, 144:30, 168:30 hours thereafter.

Secondary outcomes (2)

Part 1: AUC 0-infinity of BI 409306
Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 extrapolated to infinity.
Measured: At approximate 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14,16 hours thereafter.
Part 2: AUC0-infinity of Donepezil
This outcome measure presents the area under the concentration-time curve of donepezil in plasma over the time interval from 0 extrapolated to infinity.
Measured: At approximate 2 hours (h) prior to first administration of donepezil and 1, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 15, 24:30, 48:30, 72:30, 96:30, 120:30, 144:30, 168:30 hours thereafter.

Timeline

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

15 Jan 20164 Apr 2016

First posted21 Dec 2015 (estimated)
Study start15 Jan 2016
Primary completion16 Mar 2016
Study completion4 Apr 2016

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: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02635750
Sponsor's protocol ID: 1289.24
Other IDs: 2015-001694-40, 2015
Status last verified: Mar 2024
First submitted: 17 Dec 2015
Last updated: 20 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Investigate the Pharmacokinetic Drug-drug Interaction Following Oral Administration of BI 409306 and Donepezil in Healthy Male and Female Subjects
ClinicalTrials.gov ID: NCT02635750
Acronym / sponsor ID: 1289.24
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 15 Jan 2016 (actual)
Primary completion: 16 Mar 2016 (actual)
Study completion: 4 Apr 2016 (actual)
First posted: 21 Dec 2015 (estimated)
Results: Posted 20 Aug 2024

Clinical summary

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

Part I:

To investigate whether and to what extent donepezil affects single dose pharmacokinetics of BI 409306

Part II:

To investigate whether and to what extent BI 409306 affects the single dose pharmacokinetics of donepezil

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Part 1: 25 mg BI 409306 (R1) / 25 mg BI 409306 + 10 mg donepezil (T1)	Experimental	Drug: BI 409306, Drug: DonepezilSubjects received treatment in a fixed sequence. First BI 409306 as reference treatment (R1)), then BI 409306 + donepezil as test treatment (T1)).
Part 2: 5 mg donepezil (R2) / 5 mg donepezil + 100 mg BI 409306 (T2)	Experimental	Drug: BI 409306, Drug: DonepezilSubjects received first the reference treatment (R2) followed by a washout period, followed by the test treatment (T2).
Part 2: 5 mg donepezil + 100 mg BI 409306 (T2) / 5 mg donepezil (R2)	Experimental	Drug: BI 409306, Drug: DonepezilSubjects received first the test treatment 2 (T2) followed by a washout period, followed by the reference treatment 2 (R2)).

Who may qualify

Ages: 15 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (11 listed)

Healthy male/female subjects,
age of 18 to 55 years,
body mass index (BMI) of 18.5 to 29.9 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Male subjects, or female subjects who meet any of the following criteria starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion:

Key exclusion criteria (15 listed)

Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 60 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

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 409306	Drug	Part 1: 25 mg BI 409306 (R1) / 25 mg BI 409306 + 10 mg donepezil (T1), Part 2: 5 mg donepezil (R2) / 5 mg donepezil + 100 mg BI 409306 (T2), Part 2: 5 mg donepezil + 100 mg BI 409306 (T2) / 5 mg donepezil (R2)
Donepezil	Drug	Part 1: 25 mg BI 409306 (R1) / 25 mg BI 409306 + 10 mg donepezil (T1), Part 2: 5 mg donepezil (R2) / 5 mg donepezil + 100 mg BI 409306 (T2), Part 2: 5 mg donepezil + 100 mg BI 409306 (T2) / 5 mg donepezil (R2)

Primary outcome

Part 1: AUC0-tz of BI 409306
Time frame: Within 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours thereafter.
Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 to the last quantifiable data point.
Part 1: Cmax of BI 409306
Time frame: Within 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14,16 hours thereafter.
Maximum measured concentration of the BI 409306 in plasma.
Part 2: AUC0-tz of Donepezil
Time frame: At approximate 2 hours (h) prior to first administration of donepezil and 1, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 15, 24:30, 48:30, 72:30, 96:30, 120:30, 144:30, 168:30 hours thereafter.
Area under the concentration-time curve of donepezil in plasma over the time interval from 0 to the last quantifiable data point.
Part 2: Cmax of Donepezil
Time frame: At approximate 2 hours (h) prior to first administration of donepezil and 1, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 15, 24:30, 48:30, 72:30, 96:30, 120:30, 144:30, 168:30 hours thereafter.
Maximum measured concentration of the donepezil in plasma.

2 secondary outcomes

Part 1: AUC 0-infinity of BI 409306
Time frame: At approximate 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14,16 hours thereafter.
Part 2: AUC0-infinity of Donepezil
Time frame: At approximate 2 hours (h) prior to first administration of donepezil and 1, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 15, 24:30, 48:30, 72:30, 96:30, 120:30, 144:30, 168:30 hours thereafter.

Results and safety

Results posted to the registry on 20 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1: 25 mg BI 409306 (R1) / 25 mg BI 409306 + 10 mg Donepezil (T1)	18	18
Part 2: 5 mg Donepezil (R2) / 5 mg Donepezil + 100 mg BI 409306 (T2)	0	0
Part 2: 5 mg Donepezil + 100 mg BI 409306 (T2) / 5mg Donepezil (R2)	0	0

Primary outcome: Part 1: AUC0-tz of BI 409306

Time frame: Within 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours thereafter.. Geometric mean (Geometric Coefficient of Variation). Unit: nanomol (nmol)*hour (h)/Litre (L)

Measure	25 mg BI 409306 n = 18	25 mg BI 409306 + 10 mg Donepezil n = 17
Value	603 (95.4)	643 (86.2)

25 mg BI 409306 vs 25 mg BI 409306 + 10 mg Donepezil: Adjusted gMean ratio(%): 99.95 (90% CI 89.502 to 111.62)

Population analysed: Pharmacokinetic analysis set (PKS) included all subjects who were documented to have taken at least one dose of trial drug and provided at least one pharmacokinetic (PK) parameter that was defined as primary or secondary endpoint and was judged as PK evaluable and not affected by protocol violations. Only participants with non-missing results are reported.

Primary outcome: Part 1: Cmax of BI 409306

Time frame: Within 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14,16 hours thereafter.. Geometric mean (Geometric Coefficient of Variation). Unit: nmol/L

Measure	25 mg BI 409306 n = 18	25 mg BI 409306 + 10 mg Donepezil n = 17
Value	268 (86.2)	286 (47.8)

25 mg BI 409306 vs 25 mg BI 409306 + 10 mg Donepezil: Adjusted gMean ratio(%): 100.82 (90% CI 81.861 to 124.17)

Primary outcome: Part 2: AUC0-tz of Donepezil

Time frame: At approximate 2 hours (h) prior to first administration of donepezil and 1, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 15, 24:30, 48:30, 72:30, 96:30, 120:30, 144:30, 168:30 hours thereafter.. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram (ng)*h/ millilitre (mL)

Measure	5 mg Donepezil n = 14	5 mg Donepezil + 100 mg BI 409306 n = 14
Value	299 (20.4)	301 (20.6)

5 mg Donepezil vs 5 mg Donepezil + 100 mg BI 409306: Adjusted gMean ratio (%): 100.84 (90% CI 97.584 to 104.19)

Primary outcome: Part 2: Cmax of Donepezil

Measure	5 mg Donepezil n = 14	5 mg Donepezil + 100 mg BI 409306 n = 14
Value	6.23 (27.5)	7.04 (30.0)

5 mg Donepezil vs 5 mg Donepezil + 100 mg BI 409306: Adjusted gMean ratio(%): 113.08 (90% CI 106.41 to 120.15)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1: 25 mg BI 409306	0 of 18 (0%)	5 of 18 (27.8%)	Not reported
Part 1: 5 mg Donepezil /10 mg Donepezil	0 of 18 (0%)	15 of 18 (83.3%)	Not reported
Part 1: 25 mg BI 409306 25mg + 10 mg Donepezil	0 of 17 (0%)	5 of 17 (29.4%)	Not reported
Part 2: 5 mg Donepezil	0 of 14 (0%)	4 of 14 (28.6%)	Not reported
Part 2: 5mg Donepezil + 100 mg BI 409306	0 of 14 (0%)	12 of 14 (85.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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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 409306 and Donepezil 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 11 inclusion and 15 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 Aug 2024. 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 Aug 2024). 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?

Part 1: AUC0-tz of BI 409306 (time frame: Within 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours thereafter.). The study lists 4 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 NCT02635750.

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 Aug 2024.