HealthyPhase 1NCT01611311

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 409306

A Phase 1 study testing BI 409306 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.

Trial summary

The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in healthy young and elderly male and female volunteers following oral administration of repeated rising doses, given once daily over 14 days to young healthy genotyped and elderly healthy male/female volunteers. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 409306
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteGermany
Study dates: 1 May 2012to 1 Aug 2012
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 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

1. Healthy male/female subjects

Who cannot join

1. Any relevant deviation from healthy conditions

Trial locations and contacts

1 site in 1 country.

Germany1 site

1289.17.1 Boehringer Ingelheim Investigational Site
Neuss

Other trials in Germany

About this study

Official title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 409306 Film-coated Tablets Given Orally q.d. for 14 Days in Young and Elderly Healthy Male/Female Volunteers (Randomized, Double-blind, Placebo Controlled Within Dose Groups Phase I Study)

Conditions: Healthy
Being tested: BI 409306, Placebo

What participants receive

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

BI 409306Drug
Film-coated tablet
PlaceboDrug
Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days

Study groups in NCT01611311
Study group	Role	What they receive
Placebo (Young subjects)	Placebo comparator	Young healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days Receives: Drug: Placebo
BI 409306 - 25 milligram (mg) (Young subjects)	Experimental	Young healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days Receives: Drug: BI 409306
BI 409306 - 50 milligram (mg) (Young subjects)	Experimental	Young healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days Receives: Drug: BI 409306
Placebo (Elderly subjects)	Placebo comparator	Elderly healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days Receives: Drug: Placebo
BI 409306 - 25 milligram (mg) (Elderly subjects)	Experimental	Elderly healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days Receives: Drug: BI 409306
BI 409306 - 50 milligram (mg) (Elderly subjects)	Experimental	Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days Receives: Drug: BI 409306

What is being measured

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

Percentage of Subjects With Investigator Defined Drug-Related Adverse Events
Percentage of subjects with investigator defined drug-related Adverse Events (AEs).
Measured: From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests
Percentage of subjects with clinically relevant abnormalities in Vital signs,12-lead electrocardiogram (ECG), Clinical laboratory tests (hematology, clinical chemistry, and urinalysis), Physical examination, Suicidality assessment, Color discrimination test, Visual acuity test.
Measured: From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days

Secondary outcomes (6)

Maximum Measured Concentration of the BI 409306 in Plasma (Cmax)
Maximum measured concentration of the BI 409306 in plasma (Cmax).
Measured: PK blood samples were taken at 0, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours after drug administration.
Maximum Measured Concentration of the BI 409306 in Plasma at Steady State (Cmax, ss)
Maximum measured concentration of the BI 409306 in plasma at steady state (Cmax, ss).
Measured: PK blood samples were taken at 312, 312.167, 312.333, 312.5, 312.75, 313, 313.5, 314, 314.5, 315, 316, 318, 320, 322, 324, 326, 336, 360, 384 hours after drug administration.
Area Under the Concentration-time Curve of the BI 409306 in Plasma From 0 to 24 Hours (AUC0-24)
Area under the concentration-time curve of the BI 409306 in plasma from 0 to 24 hours (AUC0-24).
Measured: PK blood samples were taken at 0, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours after drug administration.
Area Under the Concentration-time Curve of the BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)
Area under the concentration-time curve of the BI 409306 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss).
Measured: PK blood samples were taken at 312, 312.167, 312.333, 312.5, 312.75, 313, 313.5, 314, 314.5, 315, 316, 318, 320, 322, 324, 326, 336, 360, 384 hours after drug administration.
Time From Dosing to the Maximum Concentration of the BI 409306 in Plasma (Tmax)
Time From Dosing to the Maximum Concentration of the BI 409306 in Plasma (tmax).
Measured: PK blood samples were taken at 0, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours after drug administration.
Time From Dosing to the Maximum Concentration of the BI 409306in Plasma at Steady State (Tmax,ss)
Time From Dosing to the Maximum Concentration of the BI 409306in Plasma at Steady State (Tmax,ss).
Measured: PK blood samples were taken at 312, 312.167, 312.333, 312.5, 312.75, 313, 313.5, 314, 314.5, 315, 316, 318, 320, 322, 324, 326, 336, 360, 384 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.

1 May 20121 Aug 2012

First posted4 Jun 2012 (estimated)
Study start1 May 2012
Primary completion1 Aug 2012
Study completion1 Aug 2012

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: Parallel groups
Masking: Double blind
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01611311
Sponsor's protocol ID: 1289.17
Other IDs: 2012-000052-34
Status last verified: Aug 2023
First submitted: 22 May 2012
Last updated: 8 Mar 2024
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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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 409306 Film-coated Tablets Given Orally q.d. for 14 Days in Young and Elderly Healthy Male/Female Volunteers (Randomized, Double-blind, Placebo Controlled Within Dose Groups Phase I Study)
ClinicalTrials.gov ID: NCT01611311
Acronym / sponsor ID: 1289.17
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 1 May 2012 (actual)
Primary completion: 1 Aug 2012 (actual)
Study completion: 1 Aug 2012 (actual)
First posted: 4 Jun 2012 (estimated)
Results: Posted 8 Mar 2024

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: Parallel groups
Masking: Double blind
Number of arms: 6

Arm	Type	Receives
Placebo (Young subjects)	Placebo comparator	Drug: PlaceboYoung healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days
BI 409306 - 25 milligram (mg) (Young subjects)	Experimental	Drug: BI 409306Young healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
BI 409306 - 50 milligram (mg) (Young subjects)	Experimental	Drug: BI 409306Young healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
Placebo (Elderly subjects)	Placebo comparator	Drug: PlaceboElderly healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days
BI 409306 - 25 milligram (mg) (Elderly subjects)	Experimental	Drug: BI 409306Elderly healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
BI 409306 - 50 milligram (mg) (Elderly subjects)	Experimental	Drug: BI 409306Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

1. Healthy male/female 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 409306Film-coated tablet	Drug	BI 409306 - 25 milligram (mg) (Elderly subjects), BI 409306 - 25 milligram (mg) (Young subjects), BI 409306 - 50 milligram (mg) (Elderly subjects), BI 409306 - 50 milligram (mg) (Young subjects)
PlaceboElderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days	Drug	Placebo (Elderly subjects), Placebo (Young subjects)

Primary outcome

Percentage of Subjects With Investigator Defined Drug-Related Adverse Events
Time frame: From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
Percentage of subjects with investigator defined drug-related Adverse Events (AEs).
Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests
Time frame: From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
Percentage of subjects with clinically relevant abnormalities in Vital signs,12-lead electrocardiogram (ECG), Clinical laboratory tests (hematology, clinical chemistry, and urinalysis), Physical examination, Suicidality assessment, Color discrimination test, Visual acuity test.

6 secondary outcomes

Maximum Measured Concentration of the BI 409306 in Plasma (Cmax)
Time frame: PK blood samples were taken at 0, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours after drug administration.
Maximum Measured Concentration of the BI 409306 in Plasma at Steady State (Cmax, ss)
Time frame: PK blood samples were taken at 312, 312.167, 312.333, 312.5, 312.75, 313, 313.5, 314, 314.5, 315, 316, 318, 320, 322, 324, 326, 336, 360, 384 hours after drug administration.
Area Under the Concentration-time Curve of the BI 409306 in Plasma From 0 to 24 Hours (AUC0-24)
Time frame: PK blood samples were taken at 0, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours after drug administration.
Area Under the Concentration-time Curve of the BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)
Time frame: PK blood samples were taken at 312, 312.167, 312.333, 312.5, 312.75, 313, 313.5, 314, 314.5, 315, 316, 318, 320, 322, 324, 326, 336, 360, 384 hours after drug administration.
Time From Dosing to the Maximum Concentration of the BI 409306 in Plasma (Tmax)
Time frame: PK blood samples were taken at 0, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours after drug administration.
Time From Dosing to the Maximum Concentration of the BI 409306in Plasma at Steady State (Tmax,ss)
Time frame: PK blood samples were taken at 312, 312.167, 312.333, 312.5, 312.75, 313, 313.5, 314, 314.5, 315, 316, 318, 320, 322, 324, 326, 336, 360, 384 hours after drug administration.

Results and safety

Results posted to the registry on 8 Mar 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
Placebo (Young Subjects)	4	4
BI 409306 - 25 Milligram (mg) (Young Subjects)	6	6
BI 409306 - 50 Milligram (mg) (Young Subjects)	6	6
Placebo (Elderly Subjects)	6	6
BI 409306 - 25 Milligram (mg) (Elderly Subjects)	9	9
BI 409306 - 50 Milligram (mg) (Elderly Subjects)	9	9

Primary outcome: Percentage of Subjects With Investigator Defined Drug-Related Adverse Events

Time frame: From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days. Number. Unit: Percentage of subjects

Measure	Placebo (Young Subjects) n = 4	BI 409306 - 25 Milligram (mg) (Young Subjects) n = 6	BI 409306 - 50 Milligram (mg) (Young Subjects) n = 6	Placebo (Elderly Subjects) n = 6	BI 409306 - 25 Milligram (mg) (Elderly Subjects) n = 9	BI 409306 - 50 Milligram (mg) (Elderly Subjects) n = 9
Value	50.0	50.0	66.7	50.0	55.6	44.4

Population analysed: The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.

Primary outcome: Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests

Time frame: From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days. Number. Unit: Percentage of subjects with findings

Measure	Placebo (Young Subjects) n = 4	BI 409306 - 25 Milligram (mg) (Young Subjects) n = 6	Placebo (Elderly Subjects) n = 6	BI 409306 - 25 Milligram (mg) (Elderly Subjects) n = 9	BI 409306 - 50 Milligram (mg) (Elderly Subjects) n = 9
Visual acuity test	0.0	0.0	0.0	0.0	0.0
Color discrimination test	0.0	0.0	0.0	0.0	0.0
Suicidality assessment	0.0	0.0	0.0	0.0	0.0
Physical examination	0.0	0.0	0.0	0.0	0.0
Clinical laboratory tests	0.0	16.6	0.0	0.0	11.1
12-lead electrocardiogram (ECG)	25.0	0.0	0.0	0.0	0.0
Blood pressure and pulse rate	0.0	0.0	0.0	0.0	0.0
Orthostatic intolerance	25.0	0.0	33.3	33.3	0.0

Population analysed: The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Young Subjects)	0 of 4 (0%)	2 of 4 (50%)	0 of 4
Placebo (Elderly Subjects)	0 of 6 (0%)	3 of 6 (50%)	0 of 6
BI 409306 - 25 Milligram (mg) (Young Subjects)	0 of 6 (0%)	3 of 6 (50%)	0 of 6
BI 409306 - 50 Milligram (mg) (Young Subjects)	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
BI 409306 - 25 Milligram (mg) (Elderly Subjects)	0 of 9 (0%)	6 of 9 (66.7%)	0 of 9
BI 409306 - 50 Milligram (mg) (Elderly Subjects)	0 of 9 (0%)	5 of 9 (55.6%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
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 409306 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 8 Mar 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. Some participants in this study may receive a placebo. 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 8 Mar 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?

Percentage of Subjects With Investigator Defined Drug-Related Adverse Events (time frame: From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days). 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 NCT01611311.

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 8 Mar 2024.