Healthy VolunteersPhase 1NCT02999191

Relative Bioavailability of BI 1467335 Tablet and Oral Solution, and Food Effect on Tablet in Healthy Male Subjects

A Phase 1 study testing BI 1467335 (Treatment A), BI 1467335 (Treatment B) and BI 1467335 (Treatment C) in people with Healthy Volunteers, 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

The primary objective of this trial is to investigate the relative bioavailability of BI 1467335, given as film-coated tablet compared to BI 1467335, given as oral solution. This assessment will be performed under fasted conditions. Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: BI 1467335 (Treatment A), BI 1467335 (Treatment B) and BI 1467335 (Treatment C)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteGermany
Study dates: 10 Jan 2017to 10 Apr 2017
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 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male subjects according to the investigators assessment, based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP),Pulse Rate(PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 55 years (incl.)
Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation
Willingness to comply with contraception requirements. Subjects who are sexually active, must use, with their female partner, adequate contraception throughout the study and until one month after the last administration of trial medication. Adequate methods are:
Sexual abstinence or

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A vasectomy performed at least 1 year prior to screening in combination with a barrier method (condom or diaphragm) or
Surgical sterilisation (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subjects female partner or
The use of condoms, if the female partner uses in addition an adequate contraception method, e.g., intrauterine device (IUD), hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration, or barrier method (e.g. diaphragm with spermicide) Unprotected sexual intercourse with a pregnant female partner is not allowed throughout the study and until one month after the last administration of trial medication.

Who cannot join

Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (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 50 to 90 beats per minute (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
Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)

Show all 24Show fewer

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)
Use of drugs within 30 days prior to administration of trial medication, if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication or current participation in another trial involving administration of investigational drug
Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
Inability to refrain from smoking on specified trial days
Alcohol abuse (consumption of more than 30 g per day)
Drug abuse or positive drug screening
Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial
Intention to perform excessive physical activities within 7 days prior to administration of trial medication or during the trial
Inability to comply with dietary regimen of trial site
A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms) or any other relevant ECG finding at screening
A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalaemia, or family history of Long QT Syndrome)
Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
In addition, the following trial-specific exclusion criteria apply:
Cataract in the medical history

Trial locations and contacts

1 site in 1 country.

Germany1 site

Humanpharmakologisches Zentrum Biberach
Biberach, 88397

Other trials in Germany

About this study

Official title: Relative Bioavailability of a BI 1467335 Tablet Compared to a BI 1467335 Oral Solution and the Effect of Food on the Bioavailability of the Tablet Following Oral Administration (a Randomised, Open-label, Single Dose, Three-way Crossover Trial in Healthy Male Subjects)

Conditions: Healthy Volunteers
Being tested: BI 1467335 (Treatment A), BI 1467335 (Treatment B), BI 1467335 (Treatment C)

What participants receive

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

BI 1467335 (Treatment A)Drug
BI 1467335 (Treatment B)Drug
BI 1467335 (Treatment C)Drug

Study groups in NCT02999191
Study group	Role	What they receive
BI 1467335 (Treatment A)	Experimental	Tablet under fasted conditions Receives: Drug: BI 1467335 (Treatment A)
BI 1467335 (Treatment B)	Experimental	Oral solution under fasted conditions Receives: Drug: BI 1467335 (Treatment B)
BI 1467335 (Treatment C)	Experimental	Tablet under fed conditions Receives: Drug: BI 1467335 (Treatment C)

What is being measured

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

AUC0-tz of BI 1467335
This outcome measure presents AUC0-tz [area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to the last quantifiable data point].
Measured: At -1:00h [hours (h): minutes (min)] before drug administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 24:00 h:min after drug administration.
Cmax of BI 1467335
This outcome measure presents the maximum measured concentration of BI 1467335 in plasma (Cmax of BI 1467335).
Measured: At -1:00h [hours (h): minutes (min)] before drug administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 24:00 h:min after drug administration.

Timeline

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

10 Jan 201710 Apr 2017

First posted21 Dec 2016 (estimated)
Study start10 Jan 2017
Primary completion15 Mar 2017
Study completion10 Apr 2017

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 Healthy VolunteersStudies 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: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02999191
Sponsor's protocol ID: 1386.17
Other IDs: 2016-001534-97, 2016
Status last verified: May 2021
First submitted: 19 Dec 2016
Last updated: 7 Jun 2021
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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Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of a BI 1467335 Tablet Compared to a BI 1467335 Oral Solution and the Effect of Food on the Bioavailability of the Tablet Following Oral Administration (a Randomised, Open-label, Single Dose, Three-way Crossover Trial in Healthy Male Subjects)
ClinicalTrials.gov ID: NCT02999191
Acronym / sponsor ID: 1386.17
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 10 Jan 2017 (actual)
Primary completion: 15 Mar 2017 (actual)
Study completion: 10 Apr 2017 (actual)
First posted: 21 Dec 2016 (estimated)
Results: Posted 7 Jun 2021

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: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
BI 1467335 (Treatment A)	Experimental	Drug: BI 1467335 (Treatment A)Tablet under fasted conditions
BI 1467335 (Treatment B)	Experimental	Drug: BI 1467335 (Treatment B)Oral solution under fasted conditions
BI 1467335 (Treatment C)	Experimental	Drug: BI 1467335 (Treatment C)Tablet under fed conditions

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Healthy male subjects according to the investigators assessment, based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP),Pulse Rate(PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 55 years (incl.)
Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation
Willingness to comply with contraception requirements. Subjects who are sexually active, must use, with their female partner, adequate contraception throughout the study and until one month after the last administration of trial medication. Adequate methods are:

Key exclusion criteria (24 listed)

Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (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 50 to 90 beats per minute (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 1467335 (Treatment A)	Drug	BI 1467335 (Treatment A)
BI 1467335 (Treatment B)	Drug	BI 1467335 (Treatment B)
BI 1467335 (Treatment C)	Drug	BI 1467335 (Treatment C)

Primary outcome

AUC0-tz of BI 1467335
Time frame: At -1:00h [hours (h): minutes (min)] before drug administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 24:00 h:min after drug administration.
This outcome measure presents AUC0-tz [area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to the last quantifiable data point].
Cmax of BI 1467335
Time frame: At -1:00h [hours (h): minutes (min)] before drug administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 24:00 h:min after drug administration.
This outcome measure presents the maximum measured concentration of BI 1467335 in plasma (Cmax of BI 1467335).

Results and safety

Results posted to the registry on 7 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BI 1467335: Tablets, Fasted/Solution, Fasted/Tablets, Fed	6	6
BI 1467335: Solution, Fasted/Tablets, Fed/Tablets, Fasted	6	6
BI 1467335: Tablets, Fed/Tablets, Fasted/Solution, Fasted	6	6

Primary outcome: AUC0-tz of BI 1467335

Time frame: At -1:00h [hours (h): minutes (min)] before drug administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 24:00 h:min after drug administration.. Geometric mean (Geometric Coefficient of Variation). Unit: nanomole*hour/Liter (nmol*h/L)

Measure	BI 1467335: Tablets, Fed n = 17	BI 1467335: Tablets, Fasted n = 18	BI 1467335: Solution, Fasted n = 18
Value	3.90 (90.5)	2.24 (101)	2.49 (121)

BI 1467335: Tablets, Fasted vs BI 1467335: Solution, Fasted: Ratio: 89.90 (90% CI 73.304 to 110.25), ANOVA
BI 1467335: Tablets, Fed vs BI 1467335: Tablets, Fasted: Ratio: 170.78 (90% CI 139.85 to 208.54), ANOVA

Population analysed: PharmacoKinetic Set \[PKS\]: This subject set included all subjects in the Treated Set \[All subjects who received at least one dose of study medication\] who provided at least one primary PK parameter that was not excluded due to a relevant protocol violation \[PV\] or non-evaluable plasma concentrations. One subject did not receive the dose in period 2 \[Tablets, fed\].

Primary outcome: Cmax of BI 1467335

Measure	BI 1467335: Tablets, Fed n = 17	BI 1467335: Tablets, Fasted n = 18	BI 1467335: Solution, Fasted n = 18
Value	2.55 (120)	1.85 (107)	2.20 (126)

BI 1467335: Tablets, Fasted vs BI 1467335: Solution, Fasted: Ratio: 84.17 (90% CI 64.260 to 110.24), ANOVA
BI 1467335: Tablets, Fed vs BI 1467335: Tablets, Fasted: Ratio: 136.16 (90% CI 99.885 to 185.61), ANOVA

Adverse events

Time frame: From the first day of study drug administration until 21 days after the first drug administration, up to 22 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BI 1467335: Tablets, Fasted	0 of 18 (0%)	2 of 18 (11.1%)	0 of 18
BI 1467335: Solution, Fasted	0 of 18 (0%)	5 of 18 (27.8%)	0 of 18
BI 1467335: Tablets, Fed	0 of 17 (0%)	4 of 17 (23.5%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
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 1467335 (Treatment A), BI 1467335 (Treatment B) and BI 1467335 (Treatment C) in people with Healthy Volunteers, 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 9 inclusion and 24 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 7 Jun 2021. 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 7 Jun 2021). 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-tz of BI 1467335 (time frame: At -1:00h [hours (h): minutes (min)] before drug administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 24:00 h:min 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 NCT02999191.

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 7 Jun 2021.