HealthyPhase 1NCT02248259

Drug Drug Interaction Trial With Strong CYP3A4 Inhibitor (Itraconazole) in CYP2C19 Extensive Metabolizers and Poor Metabolizers

A Phase 1 study testing BI 409306 and Itraconazole 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

Search all trials

Trial summary

The objective of the current study is to evaluate the effect of once daily itraconazole on the pharmacokinetics of BI 409306 in poor (PM) and extensive metabolisers (EM) of CYP2C19. 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 and Itraconazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteSouth Korea
Study dates: 8 Oct 2014to 8 Jan 2015
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 CYP2C19 genotyped male volunteers according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR, respiratory rate, body temperature), 12-lead ECG, ophthalmologic exam, clinical laboratory tests
Korean ethnicity according to the following criteria: be a current Korean passport or national identification card holder, and have parents and grandparents who were all born in Korea
Age 20 or older than 20 and 45 or younger than 45 years
BMI (Body Mass Index) 18.5 or more than 18.5 and BMI 25 or less than 25 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.

Who cannot join

Any finding of the medical examination (including BP, PR, respiratory rate, body temperature and ECG) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy, hernia surgery)
Diseases of the central nervous system (including but not limited to any kind of seizures, migraine, stroke or psychiatric disorders) within the past 6 month
History of relevant orthostatic hypotension, fainting spells or blackouts.

Show all 23Show fewer

Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
Intake of drugs with a long half-life (longer than 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
Participation in another trial with an investigational drug within two months prior to administration or during the trial
Smoker (more than 10 cigarettes or more than 3 cigars or more than 3 pipes/day)
Inability to refrain from smoking on trial days
Alcohol abuse (more than 20 g/day)
Drug abuse
Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
Excessive physical activities (within one week prior to administration or during the trial)
Any laboratory value outside the reference range that is of clinical relevance
Inability to comply with dietary regimen of trial site
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval more than 450 ms)
A history of additional risk factors for Torsade des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
Abnormality on color vision test or any other finding on ophthalmologic exam that is clinically deemed to potentially interfere with the safety assessment of this trial
Subjects who do not agree to minimize the risk of female partners becoming pregnant from the first dosing day until two month after the study completion. Acceptable methods of contraception comprises barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive since at least two month)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

1289.23.8201 Boehringer Ingelheim Investigational Site
Seoul

Other trials in South Korea

About this study

Official title: Open-label, Randomised, Two-way Crossover Study to Assess the Effect of Once Daily Itraconazole on the Pharmacokinetics of BI 409306 After a Single Oral Dose in Healthy Male Volunteers Genotyped as Poor and Extensive Metabolizers of CYP2C19

The objective of the current study is to evaluate the effect of once daily itraconazole on the pharmacokinetics of BI 409306 in poor (PM) and extensive metabolisers (EM) of CYP2C19.

Conditions: Healthy
Being tested: BI 409306, Itraconazole

What participants receive

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

BI 409306Drug
Oral single dose of BI 409306
ItraconazoleDrug
Oral dose, twice daily on Day -3, once daily on Day -2 to Day 2 of Itraconazole

Study groups in NCT02248259
Study group	Role	What they receive
Extensive Metabolisers: Ref / Test	Experimental	Participants who were extensive metabolisers received two treatments in a randomised order, the treatments were: * Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1). * Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1. Receives: Drug: BI 409306; Drug: Itraconazole
Poor Metabolisers: Ref / Test	Experimental	Participants who were poor metabolisers received two treatments in a randomised order, the treatments were: * Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1). * Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1. Receives: Drug: BI 409306; Drug: Itraconazole
Extensive Metabolisers: Test / Ref	Experimental	Participants who were extensive metabolisers received two treatments in a randomised order, the treatments were: * Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1. * Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1). Receives: Drug: BI 409306; Drug: Itraconazole
Poor Metabolisers: Test / Ref	Experimental	Participants who were poor metabolisers received two treatments in a randomised order, the treatments were: * Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1. * Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1). Receives: Drug: BI 409306; Drug: Itraconazole

What is being measured

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

AUC0-infinity of BI 409306 and Its Metabolites
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) of BI 409306 and its metabolites CD 13896 and CD 14084
Measured: 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration
Cmax of BI 409306 and Its Metabolites
Maximum measured concentration of the analyte in plasma (Cmax) of BI 409306 and its metabolites CD 13896 and CD 14084
Measured: 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration

Secondary outcomes (3)

AUC0-tz of BI 409306 and Its Metabolites
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable plasma concentration (AUC0-tz) of BI 409306 and its metabolites CD 13896 and CD 14084
Measured: 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration
Tmax of BI 409306 and Its Metabolites
Time from dosing to the maximum concentration of the analyte in plasma (tmax) of BI 409306 and its metabolites CD 13896 and CD 14084
Measured: 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration
t1/2 of BI 409306 and Its Metabolites
Terminal half-life of the analyte in plasma (t1/2) of BI 409306 and its metabolites CD 13896 and CD 14084
Measured: 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration

Timeline

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

8 Oct 20148 Jan 2015

First posted25 Sep 2014 (estimated)
Study start8 Oct 2014
Primary completion7 Jan 2015
Study completion8 Jan 2015

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: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02248259
Sponsor's protocol ID: 1289.23
Status last verified: Apr 2024
First submitted: 22 Sep 2014
Last updated: 25 Apr 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?

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Study at a glance

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

Official title: Open-label, Randomised, Two-way Crossover Study to Assess the Effect of Once Daily Itraconazole on the Pharmacokinetics of BI 409306 After a Single Oral Dose in Healthy Male Volunteers Genotyped as Poor and Extensive Metabolizers of CYP2C19
ClinicalTrials.gov ID: NCT02248259
Acronym / sponsor ID: 1289.23
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 8 Oct 2014 (actual)
Primary completion: 7 Jan 2015 (actual)
Study completion: 8 Jan 2015 (actual)
First posted: 25 Sep 2014 (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.

The objective of the current study is to evaluate the effect of once daily itraconazole on the pharmacokinetics of BI 409306 in poor (PM) and extensive metabolisers (EM) of CYP2C19.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Extensive Metabolisers: Ref / Test	Experimental	Drug: BI 409306, Drug: ItraconazoleParticipants who were extensive metabolisers received two treatments in a randomised order, the treatments were: * Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1). * Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.
Poor Metabolisers: Ref / Test	Experimental	Drug: BI 409306, Drug: ItraconazoleParticipants who were poor metabolisers received two treatments in a randomised order, the treatments were: * Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1). * Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.
Extensive Metabolisers: Test / Ref	Experimental	Drug: BI 409306, Drug: ItraconazoleParticipants who were extensive metabolisers received two treatments in a randomised order, the treatments were: * Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1. * Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).
Poor Metabolisers: Test / Ref	Experimental	Drug: BI 409306, Drug: ItraconazoleParticipants who were poor metabolisers received two treatments in a randomised order, the treatments were: * Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1. * Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).

Who may qualify

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

Key inclusion criteria (5 listed)

Healthy CYP2C19 genotyped male volunteers according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR, respiratory rate, body temperature), 12-lead ECG, ophthalmologic exam, clinical laboratory tests
Korean ethnicity according to the following criteria: be a current Korean passport or national identification card holder, and have parents and grandparents who were all born in Korea
Age 20 or older than 20 and 45 or younger than 45 years
BMI (Body Mass Index) 18.5 or more than 18.5 and BMI 25 or less than 25 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.

Key exclusion criteria (23 listed)

Any finding of the medical examination (including BP, PR, respiratory rate, body temperature and ECG) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy, hernia surgery)
Diseases of the central nervous system (including but not limited to any kind of seizures, migraine, stroke or psychiatric disorders) within the past 6 month

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 409306Oral single dose of BI 409306	Drug	Extensive Metabolisers: Ref / Test, Extensive Metabolisers: Test / Ref, Poor Metabolisers: Ref / Test, Poor Metabolisers: Test / Ref
ItraconazoleOral dose, twice daily on Day -3, once daily on Day -2 to Day 2 of Itraconazole	Drug	Extensive Metabolisers: Ref / Test, Extensive Metabolisers: Test / Ref, Poor Metabolisers: Ref / Test, Poor Metabolisers: Test / Ref

Primary outcome

AUC0-infinity of BI 409306 and Its Metabolites
Time frame: 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) of BI 409306 and its metabolites CD 13896 and CD 14084
Cmax of BI 409306 and Its Metabolites
Time frame: 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration
Maximum measured concentration of the analyte in plasma (Cmax) of BI 409306 and its metabolites CD 13896 and CD 14084

3 secondary outcomes

AUC0-tz of BI 409306 and Its Metabolites
Time frame: 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration
Tmax of BI 409306 and Its Metabolites
Time frame: 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration
t1/2 of BI 409306 and Its Metabolites
Time frame: 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) 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
Extensive Metabolisers: Ref / Test	6	6
Poor Metabolisers: Ref / Test	6	6
Extensive Metabolisers: Test / Ref	7	6
Poor Metabolisers: Test / Ref	6	6

Primary outcome: AUC0-infinity of BI 409306 and Its Metabolites

Time frame: 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration. Geometric mean (Geometric Coefficient of Variation). Unit: nanomole (nmol)*hour (h) /Liter (L)

Measure	Extensive Metabolisers: Ref. Treatment n = 12	Extensive Metabolisers: Test Treatment n = 12	Poor Metabolisers: Ref. Treatment n = 12	Poor Metabolisers: Test Treatment n = 12
BI 409306	547 (71.6)	621 (68.8)	1560 (45.5)	1370 (39.4)
CD 13896	389 (26.4)	347 (19.2)	178 (20.0)	165 (14.3)
CD 14084	2120 (10.9)	2110 (12.6)	1810 (15.7)	1890 (14.2)

Extensive Metabolisers: Ref. Treatment vs Extensive Metabolisers: Test Treatment: Geometric mean ratio (%): 113.60 (90% CI 100.522 to 128.376)
Poor Metabolisers: Ref. Treatment vs Poor Metabolisers: Test Treatment: Geometric mean ratio (%): 87.98 (90% CI 77.839 to 99.452)
Extensive Metabolisers: Ref. Treatment vs Extensive Metabolisers: Test Treatment: Geometric mean ratio (%): 89.21 (90% CI 84.636 to 94.021)

Population analysed: Pharmacokinetic set (PKS) which included all treated subjects who provided at least one evaluable primary or secondary endpoint in any of the study periods without important protocol violations with respect to the statistical evaluation of relative bioavailability.

Primary outcome: Cmax of BI 409306 and Its Metabolites

Measure	Extensive Metabolisers: Ref. Treatment n = 12	Extensive Metabolisers: Test Treatment n = 12	Poor Metabolisers: Ref. Treatment n = 12	Poor Metabolisers: Test Treatment n = 12
BI 409306	264 (67.8)	246 (60.2)	564 (50.5)	432 (35.4)
CD 13896	139 (41.6)	110 (35.5)	44.9 (33.3)	42.8 (16.2)
CD 14084	714 (21.5)	620 (19.1)	470 (35.8)	505 (20.3)

Extensive Metabolisers: Ref. Treatment vs Extensive Metabolisers: Test Treatment: Geometric mean ratio (%): 93.26 (90% CI 80.377 to 108.217)
Poor Metabolisers: Ref. Treatment vs Poor Metabolisers: Test Treatment: Geometric mean ratio (%): 76.65 (90% CI 60.482 to 97.141)
Extensive Metabolisers: Ref. Treatment vs Extensive Metabolisers: Test Treatment: Geometric mean ratio (%): 78.71 (90% CI 67.304 to 92.052)

Population analysed: PKS

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first trial drug intake until end of washout period or end of study visit (inclusive), up to 23 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Extensive Metabolizers: Itra	0 of 13 (0%)	3 of 13 (23.1%)	Not reported
Extensive Metabolizers: BI 409306	0 of 12 (0%)	1 of 12 (8.3%)	Not reported
Extensive Metabolizers: Itra+BI 409306	0 of 12 (0%)	3 of 12 (25%)	Not reported
Poor Metabolizers: Itra	0 of 12 (0%)	1 of 12 (8.3%)	Not reported
Poor Metabolizers: BI 409306	0 of 12 (0%)	3 of 12 (25%)	Not reported
Poor Metabolizers: Itra+BI 409306	0 of 12 (0%)	0 of 12 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 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 Itraconazole 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 23 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 Apr 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. 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?

AUC0-infinity of BI 409306 and Its Metabolites (time frame: 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) 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 NCT02248259.

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 Apr 2024.