HealthyPhase 1NCT01841112

Safety, Tolerability and Pharmacokinetics of BI 409306 Tablets in Healthy Asian Male Volunteers

A Phase 1 study testing BI-409306 25 milligram (mg) SD, BI-409306 50 mg SD and BI-409306 100 mg SD in people with Healthy, run by Boehringer Ingelheim at 1 site in South Korea.

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

Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 409306 tablets in healthy Chinese and Japanese male volunteers of a known genotype as specified in the study protocol. Read more about this study

Who is it for?: Ages 20 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI-409306 25 milligram (mg) SD, BI-409306 50 mg SD and BI-409306 100 mg SD
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 65 participants
Where: 1 siteSouth Korea
Study dates: 22 Apr 2013to 18 Jul 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 20 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male Chinese and Japanese volunteers
Age between 20 and 45 years
BMI between 18.5 and 25 kg/m2 (Body Mass Index)
Known genotype as specified in the study protocol
Subjects must be able to understand and comply with study requirements

Who cannot join

1. Any deviation from healthy condition

Trial locations and contacts

1 site in 1 country.

South Korea1 site

1289.4.8201 Boehringer Ingelheim Investigational Site
Seoul

Other trials in South Korea

About this study

Official title: Safety, Tolerability and Pharmacokinetics of Single Oral Doses of BI 409306 (Tablet) in Healthy Chinese and Japanese Male Volunteers and Multiple Oral Doses of BI 409306 (Tablet) in Healthy Japanese Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)

Conditions: Healthy
Being tested: Placebo, BI-409306 25 milligram (mg) SD, BI-409306 50 mg SD, BI-409306 100 mg SD, BI-409306 100 mg MD

What participants receive

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

PlaceboDrug
Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment
BI-409306 25 milligram (mg) SDDrug
Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
BI-409306 50 mg SDDrug
Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
BI-409306 100 mg SDDrug
Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
BI-409306 100 mg MDDrug
Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9

Study groups in NCT01841112
Study group	Role	What they receive
Placebo	Placebo comparator	Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment Receives: Drug: Placebo
BI-409306 25 milligram (mg) SD	Experimental	Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 Receives: Drug: BI-409306 25 milligram (mg) SD
BI-409306 50 mg SD	Experimental	Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 Receives: Drug: BI-409306 50 mg SD
BI-409306 100 mg SD	Experimental	Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 Receives: Drug: BI-409306 100 mg SD
BI-409306 100 mg MDBI-409306 100 mg SD & MD	Experimental	Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9. A wash-out period of 48 hours was included before the second dose (first does of multipled dose segment) was administered. Subjects were considered for both single dose (following first dose) and multiple dose purposes. Receives: Drug: BI-409306 100 mg MD

What is being measured

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

Percentage (%) of Subjects With Drug-related Adverse Events (AEs)
Percentage (%) of subjects with drug-related adverse events (AEs).
Measured: From first drug administration until 11 days after last dose of study medication, up to 18 days.

Secondary outcomes (9)

Maximum Measured Concentration of a Single Dose of BI 409306 in Plasma (Cmax)
Maximum measured concentration of a single dose of BI 409306 in plasma (Cmax).
Measured: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.
Area Under the Concentration-time Curve of a Single Dose of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)
Area under the concentration-time curve of a single dose of BI 409306 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity).
Measured: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.
Area Under the Concentration-time Curve of a Single Dose of BI 409306 in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of a single dose of BI 409306 in plasma over the time interval 0 to the last quantifiable data point (AUC0-tz).
Measured: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.
Maximum Measured Concentration of the Metabolite CD 13896 in Plasma (Cmax)
Maximum measured concentration of the metabolite CD 13896 in plasma (Cmax) after single administration of BI 409306.
Measured: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.
Maximum Measured Concentration of the Metabolite CD 14084 in Plasma (Cmax)
Maximum measured concentration of the metabolite CD 14084 in plasma (Cmax) after single administration of BI 409306.
Measured: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.
Area Under the Concentration-time Curve of the Metabolite CD 13896 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)
Area under the concentration-time curve of the metabolite CD 13896 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity) after single administration of BI 409306.
Measured: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.
Area Under the Concentration-time Curve of the Metabolite CD 14084 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)
Area under the concentration-time curve of the metabolite CD 14084 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity) after single administration of BI 409306.
Measured: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.
Area Under the Concentration-time Curve of the Metabolite CD 13896 in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz).
Area under the concentration-time curve of the metabolite CD 13896 in plasma over the time interval 0 to the last quantifiable data point (AUC0-tz) after single administration of BI 409306.
Measured: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.
Area Under the Concentration-time Curve of the Metabolite CD 14084 in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz).
Area under the concentration-time curve of the metabolite CD 14084 in plasma over the time interval 0 to the last quantifiable data point (AUC0-tz) after single administration of BI 409306.
Measured: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.

Timeline

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

22 Apr 201318 Jul 2013

First posted26 Apr 2013 (estimated)
Study start22 Apr 2013
Primary completion18 Jul 2013
Study completion18 Jul 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: Parallel groups
Masking: Double blind
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01841112
Sponsor's protocol ID: 1289.4
Status last verified: Jun 2024
First submitted: 24 Apr 2013
Last updated: 25 Jun 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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Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability and Pharmacokinetics of Single Oral Doses of BI 409306 (Tablet) in Healthy Chinese and Japanese Male Volunteers and Multiple Oral Doses of BI 409306 (Tablet) in Healthy Japanese Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)
ClinicalTrials.gov ID: NCT01841112
Acronym / sponsor ID: 1289.4
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 22 Apr 2013 (actual)
Primary completion: 18 Jul 2013 (actual)
Study completion: 18 Jul 2013 (actual)
First posted: 26 Apr 2013 (estimated)
Results: Posted 28 May 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: 5

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboSubjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment
BI-409306 25 milligram (mg) SD	Experimental	Drug: BI-409306 25 milligram (mg) SDSubjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
BI-409306 50 mg SD	Experimental	Drug: BI-409306 50 mg SDSubjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
BI-409306 100 mg SD	Experimental	Drug: BI-409306 100 mg SDSubjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1
BI-409306 100 mg MDBI-409306 100 mg SD & MD	Experimental	Drug: BI-409306 100 mg MDSubjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9. A wash-out period of 48 hours was included before the second dose (first does of multipled dose segment) was administered. Subjects were considered for both single dose (following first dose) and multiple dose purposes.

Who may qualify

Ages: 20 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy male Chinese and Japanese volunteers
Age between 20 and 45 years
BMI between 18.5 and 25 kg/m2 (Body Mass Index)
Known genotype as specified in the study protocol
Subjects must be able to understand and comply with study requirements

Key exclusion criteria (1 listed)

1. Any deviation from healthy condition

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
PlaceboSubjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment	Drug	Placebo
BI-409306 25 milligram (mg) SDSubjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1	Drug	BI-409306 25 milligram (mg) SD
BI-409306 50 mg SDSubjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1	Drug	BI-409306 50 mg SD
BI-409306 100 mg SDSubjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1	Drug	BI-409306 100 mg SD
BI-409306 100 mg MDSubjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9	Drug	BI-409306 100 mg MDBI-409306 100 mg SD & MD

Primary outcome

Percentage (%) of Subjects With Drug-related Adverse Events (AEs)
Time frame: From first drug administration until 11 days after last dose of study medication, up to 18 days.
Percentage (%) of subjects with drug-related adverse events (AEs).

9 secondary outcomes

Maximum Measured Concentration of a Single Dose of BI 409306 in Plasma (Cmax)
Time frame: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.
Area Under the Concentration-time Curve of a Single Dose of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)
Time frame: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.
Area Under the Concentration-time Curve of a Single Dose of BI 409306 in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.
Maximum Measured Concentration of the Metabolite CD 13896 in Plasma (Cmax)
Time frame: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.
Maximum Measured Concentration of the Metabolite CD 14084 in Plasma (Cmax)
Time frame: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.
Area Under the Concentration-time Curve of the Metabolite CD 13896 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)
Time frame: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.
Area Under the Concentration-time Curve of the Metabolite CD 14084 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)
Time frame: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.
Area Under the Concentration-time Curve of the Metabolite CD 13896 in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz).
Time frame: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.
Area Under the Concentration-time Curve of the Metabolite CD 14084 in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz).
Time frame: PK plasma samples: 2 hours before drug administration and 10, 20, 30, 45 minutes, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 14, 24 hours for SD segment after drug administration.

Results and safety

Results posted to the registry on 28 May 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	16	15
BI-409306 25 Milligram (mg) SD	12	11
BI-409306 50 mg SD	12	11
BI-409306 100 mg SD	19	19
BI-409306 100 mg SD & MD	6	6

Primary outcome: Percentage (%) of Subjects With Drug-related Adverse Events (AEs)

Time frame: From first drug administration until 11 days after last dose of study medication, up to 18 days.. Number. Unit: Percentage of Participants

Measure	Placebo n = 15	BI-409306 25 Milligram (mg) SD n = 11	BI-409306 50 mg SD n = 11	BI-409306 100 mg SD n = 19	BI-409306 100 mg MD-PM n = 6	BI-409306 100 mg SD-PM n = 6
Value	13.3	9.1	36.4	57.9	83.3	83.3

Population analysed: Treated Set (TS) included all randomised subjects who were documented to have received at least one dose of study medication.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 11 days after last dose of study medication, up to 18 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 15 (0%)	2 of 15 (13.3%)	Not reported
BI-409306 25 Milligram (mg) SD	0 of 11 (0%)	1 of 11 (9.1%)	Not reported
BI-409306 50 mg SD	0 of 11 (0%)	5 of 11 (45.5%)	Not reported
BI-409306 100 mg SD	0 of 19 (0%)	11 of 19 (57.9%)	Not reported
BI-409306 100 mg SD-PM	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
BI-409306 100 mg MD-PM	0 of 6 (0%)	5 of 6 (83.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 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 25 milligram (mg) SD, BI-409306 50 mg SD and BI-409306 100 mg SD in people with Healthy, run by Boehringer Ingelheim at 1 site in South Korea.

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 5 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 25 Jun 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 South Korea. 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 28 May 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 Drug-related Adverse Events (AEs) (time frame: From first drug administration until 11 days after last dose of study medication, up to 18 days.). 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 NCT01841112.

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 25 Jun 2024.