Healthy VolunteersPhase 1NCT03004404

To Assess Safety, Tolerability and Pharmacokinetics of BI 730357 in Healthy Male Volunteers

A Phase 1 study testing BI 730357 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

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: BI 730357
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 84 participants
Where: 1 siteGermany
Study dates: 12 Jan 2017to 15 Aug 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 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male according to the Investigator's 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 45 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

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)

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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)
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 (corrected QT) 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 30 g per day for males)
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 one week 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, hypokalemia, 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:
Male subjects with Women of childbearing potential (WOCBP) partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication

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: A Partially Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 730357 Administered as Oral Solution and Tablets to Healthy Subjects, and a Randomized, Open-label, Single-dose, Three-way Cross-over Bioavailability Comparison of BI 730357 as Tablet Versus Oral Solution and Tablet With and Without Food

The primary objective of the Single Rising Dose (SRD) part (trial part 1) is to investigate the safety and tolerability of BI 730357 in healthy subjects following oral administration of single rising doses after fasting and/or non-fasting conditions. The secondary objective is the exploration of the pharmacokinetics (PK) including dose proportionality, and pharmacodynamics of BI 730357 after single dosing.

The objective of the Bioavailability (BA) part (trial part 2) will be to explore the relative bioavailability of tablet fasted versus oral solution fasted and the influence of food on the bioavailability of tablet fasted versus tablet fed.

Conditions: Healthy Volunteers
Being tested: Placebo, BI 730357

What participants receive

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

PlaceboDrug
Placebo
BI 730357Drug
powder for reconstitution of an oral solution (PfoS)
BI 730357Drug
BI 730357 film-coated tablet

Study groups in NCT03004404
Study group	Role	What they receive
SRD part-Dose group 1: BI 730357 PfOS 2 mg Fasted	Experimental	Participants were administered on Day 1 a single oral dose of 2 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 2 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication. Receives: Drug: BI 730357
Placebo	Placebo comparator	This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants of the first cohort of each dose group (DG) were not randomized. In the second cohort of each DG participants were assigned to active treatment or placebo in a 3:1 allocation ratio. Receives: Drug: Placebo
SRD part-Dose group 2: BI 730357 PfOS 8 mg Fasted	Experimental	Participants were administered on Day 1 a single oral dose of 8 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication. Receives: Drug: BI 730357
SRD part-Dose group 3: BI 730357 tablet 25 mg Fasted	Experimental	Participants were administered on Day 1 a single oral dose of 25 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication. Receives: Drug: BI 730357
SRD part-Dose group 4: BI 730357 tablet 50 mg Fasted	Experimental	Participants were administered on Day 1 a single oral dose of 50 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication. Receives: Drug: BI 730357
SRD part-Dose group 5: BI 730357 tablet(s) 100 mg Fasted	Experimental	Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 730357 film-coated tablets (2x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication. Receives: Drug: BI 730357
SRD part-Dose group 6: BI 730357 tablet(s) 200 mg Fasted	Experimental	Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (4x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication. Receives: Drug: BI 730357
SRD part-Dose group 7: BI 730357 tablet(s) 400 mg Fasted	Experimental	Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication. Receives: Drug: BI 730357
SRD part-Dose group 8-9: BI 730357 tablet(s) 400 mg Fed	Experimental	The same participants conformed the Dose group (DG) 8 and DG 9. DG 8: Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard continental breakfast. DG 9: Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. Both treatment periods were separated by a wash-out phase of at least 14 days between drug administration of DG 8 and DG 9. One authorized employee of the trial site was witness of the administration of the trial medication. Receives: Drug: BI 730357
SRD part-Dose group 10: BI 730357 tablet(s) 800 mg Fed	Experimental	Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (16x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. One authorized employee of the trial site was witness of the administration of the trial medication. Receives: Drug: BI 730357
BA Part: R/T2/T1	Experimental	Participants were orally administered 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state. Followed by 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration. Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state. The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication. Receives: Drug: BI 730357
BA Part: R/T1/T2	Experimental	Participants were orally administered 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state. Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state. Followed by 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration. The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication. Receives: Drug: BI 730357
BA Part: T2/R/T1	Experimental	Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration. Followed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state. Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state. The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication. Receives: Drug: BI 730357
BA Part: T2/T1/R	Experimental	Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration. Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state. Followed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state. The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication. Receives: Drug: BI 730357
BA Part: T1/R/T2	Experimental	Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state. Followed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state. Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration. The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication. Receives: Drug: BI 730357
BA Part: T1/T2/R	Experimental	BA Part: T1/T2/R Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state. Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration. Followed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state. The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication. Receives: Drug: BI 730357

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 adverse reactions, assessed by investigator-defined drug-related adverse events (AEs) are reported.
Fed1 means intake of continental breakfast; fed2 means intake of high-fat breakfast. The 400 mg tablet fed1 and fed2 treatments were administered to the same participants.
Measured: SRD 1-7, 10: From first drug administration until end of trial (EOT), up to 13 days. SRD 8-9: From first drug administration until end of trial (EOT), up to 27 days. BA: From first drug administration until end of trial (EOT), up to 41 days.

Secondary outcomes (2)

Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
Area under the concentration-time curve of BI 730357 in plasma over the time interval from 0 extrapolated to infinity is reported.
Fed1 means intake of continental breakfast; fed2 means intake of high-fat breakfast. The 400 mg tablet fed1 and fed2 treatments were administered to the same subjects.
Measured: SRD & BA Part: Within 3 hours (h) prior administration, and 0.5h, 1.0h, 1.5h, 2.0h, 2.5h, 3.0h, 4.0h, 5.0h, 6.0h, 8.0h, 10.0h, 12.0h, 24.0h, 34.0h, 48.0h, 72.0h, 96.0h and 168.0h after drug administration
Maximum Measured Concentration of BI 730357 in Plasma (Cmax)
Maximum measured concentration of BI 730357 in plasma is reported.
Fed1 means intake of continental breakfast; Fed2 means intake of high-fat breakfast. The 400 mg tablet fed1 and fed2 treatments were administered to the same subjects.
Measured: SRD & BA Part: Within 3 hours (h) prior administration, and 0.5h, 1.0h, 1.5h, 2.0h, 2.5h, 3.0h, 4.0h, 5.0h, 6.0h, 8.0h, 10.0h, 12.0h, 24.0h, 34.0h, 48.0h, 72.0h, 96.0h and 168.0h after drug administration

Timeline

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

12 Jan 201715 Aug 2017

First posted28 Dec 2016 (estimated)
Study start12 Jan 2017
Primary completion15 Aug 2017
Study completion15 Aug 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: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03004404
Sponsor's protocol ID: 1407.1
Other IDs: 2016-003047-11, 2016
Status last verified: Aug 2023
First submitted: 23 Dec 2016
Last updated: 16 Aug 2023
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 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Partially Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 730357 Administered as Oral Solution and Tablets to Healthy Subjects, and a Randomized, Open-label, Single-dose, Three-way Cross-over Bioavailability Comparison of BI 730357 as Tablet Versus Oral Solution and Tablet With and Without Food
ClinicalTrials.gov ID: NCT03004404
Acronym / sponsor ID: 1407.1
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 12 Jan 2017 (actual)
Primary completion: 15 Aug 2017 (actual)
Study completion: 15 Aug 2017 (actual)
First posted: 28 Dec 2016 (estimated)
Results: Posted 16 Aug 2023

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: Single blind (participant)
Number of arms: 16

Arm	Type	Receives
SRD part-Dose group 1: BI 730357 PfOS 2 mg Fasted	Experimental	Drug: BI 730357Participants were administered on Day 1 a single oral dose of 2 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 2 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.
Placebo	Placebo comparator	Drug: PlaceboThis arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants of the first cohort of each dose group (DG) were not randomized. In the second cohort of each DG participants were assigned to active treatment or placebo in a 3:1 allocation ratio.
SRD part-Dose group 2: BI 730357 PfOS 8 mg Fasted	Experimental	Drug: BI 730357Participants were administered on Day 1 a single oral dose of 8 milligram (mg) of BI 730357 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.
SRD part-Dose group 3: BI 730357 tablet 25 mg Fasted	Experimental	Drug: BI 730357Participants were administered on Day 1 a single oral dose of 25 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.
SRD part-Dose group 4: BI 730357 tablet 50 mg Fasted	Experimental	Drug: BI 730357Participants were administered on Day 1 a single oral dose of 50 milligram (mg) of BI 730357 film-coated tablet together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.
SRD part-Dose group 5: BI 730357 tablet(s) 100 mg Fasted	Experimental	Drug: BI 730357Participants were administered on Day 1 a single oral dose of 100 milligram (mg) of BI 730357 film-coated tablets (2x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.
SRD part-Dose group 6: BI 730357 tablet(s) 200 mg Fasted	Experimental	Drug: BI 730357Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (4x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.
SRD part-Dose group 7: BI 730357 tablet(s) 400 mg Fasted	Experimental	Drug: BI 730357Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water in fasted state. One authorized employee of the trial site was witness of the administration of the trial medication.
SRD part-Dose group 8-9: BI 730357 tablet(s) 400 mg Fed	Experimental	Drug: BI 730357The same participants conformed the Dose group (DG) 8 and DG 9. DG 8: Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard continental breakfast. DG 9: Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (8x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. Both treatment periods were separated by a wash-out phase of at least 14 days between drug administration of DG 8 and DG 9. One authorized employee of the trial site was witness of the administration of the trial medication.
SRD part-Dose group 10: BI 730357 tablet(s) 800 mg Fed	Experimental	Drug: BI 730357Participants were administered on Day 1 a single oral dose of 200 milligram (mg) of BI 730357 film-coated tablets (16x50mg) together with about 240 milliliter (mL) of water, 30 minutes (min) prior dose administration the participants consumed a standard high fat breakfast. One authorized employee of the trial site was witness of the administration of the trial medication.
BA Part: R/T2/T1	Experimental	Drug: BI 730357Participants were orally administered 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state. Followed by 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration. Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state. The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.
BA Part: R/T1/T2	Experimental	Drug: BI 730357Participants were orally administered 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state. Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state. Followed by 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration. The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.
BA Part: T2/R/T1	Experimental	Drug: BI 730357Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration. Followed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state. Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state. The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.
BA Part: T2/T1/R	Experimental	Drug: BI 730357Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration. Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state. Followed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state. The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.
BA Part: T1/R/T2	Experimental	Drug: BI 730357Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state. Followed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state. Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration. The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.
BA Part: T1/T2/R	Experimental	Drug: BI 730357BA Part: T1/T2/R Participants received 25 mg of BI 730357 powder for reconstitution of an oral solution (PfOS) reconstituted in solvent for oral solution 2.5 milliliter (mL) (Macrogol 400 (Polyethylene glycol 400) (test treatment T1) in fasted state. Participants were orally administered 25 mg of BI 730357 film-coated tablet in a fed state (test treatment T2), a high-fat, high-calorie breakfast was served 30 min before dose administration. Followed by 25 mg of BI 730357 as film-coated tablet (Reference treatment R) in fasted state. The 3 treatments were administered with 240 mL of water and were separated by a washout period of at least 8 days. One authorized employee of the trial site was witness of the administration of the trial medication.

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy male according to the Investigator's 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 45 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

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
PlaceboPlacebo	Drug	Placebo
BI 730357powder for reconstitution of an oral solution (PfoS)	Drug	BA Part: R/T1/T2, BA Part: R/T2/T1, BA Part: T1/R/T2, BA Part: T1/T2/R, BA Part: T2/R/T1, BA Part: T2/T1/R, SRD part-Dose group 1: BI 730357 PfOS 2 mg Fasted, SRD part-Dose group 2: BI 730357 PfOS 8 mg Fasted
BI 730357BI 730357 film-coated tablet	Drug	BA Part: R/T1/T2, BA Part: R/T2/T1, BA Part: T1/R/T2, BA Part: T1/T2/R, BA Part: T2/R/T1, BA Part: T2/T1/R, SRD part-Dose group 10: BI 730357 tablet(s) 800 mg Fed, SRD part-Dose group 3: BI 730357 tablet 25 mg Fasted, SRD part-Dose group 4: BI 730357 tablet 50 mg Fasted, SRD part-Dose group 5: BI 730357 tablet(s) 100 mg Fasted, SRD part-Dose group 6: BI 730357 tablet(s) 200 mg Fasted, SRD part-Dose group 7: BI 730357 tablet(s) 400 mg Fasted, SRD part-Dose group 8-9: BI 730357 tablet(s) 400 mg Fed

Primary outcome

Percentage of Subjects With Drug-related Adverse Events (AEs)
Time frame: SRD 1-7, 10: From first drug administration until end of trial (EOT), up to 13 days. SRD 8-9: From first drug administration until end of trial (EOT), up to 27 days. BA: From first drug administration until end of trial (EOT), up to 41 days.
Percentage of subjects with adverse reactions, assessed by investigator-defined drug-related adverse events (AEs) are reported. Fed1 means intake of continental breakfast; fed2 means intake of high-fat breakfast. The 400 mg tablet fed1 and fed2 treatments were administered to the same participants.

2 secondary outcomes

Area Under the Concentration-time Curve of BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
Time frame: SRD & BA Part: Within 3 hours (h) prior administration, and 0.5h, 1.0h, 1.5h, 2.0h, 2.5h, 3.0h, 4.0h, 5.0h, 6.0h, 8.0h, 10.0h, 12.0h, 24.0h, 34.0h, 48.0h, 72.0h, 96.0h and 168.0h after drug administration
Maximum Measured Concentration of BI 730357 in Plasma (Cmax)
Time frame: SRD & BA Part: Within 3 hours (h) prior administration, and 0.5h, 1.0h, 1.5h, 2.0h, 2.5h, 3.0h, 4.0h, 5.0h, 6.0h, 8.0h, 10.0h, 12.0h, 24.0h, 34.0h, 48.0h, 72.0h, 96.0h and 168.0h after drug administration

Results and safety

Results posted to the registry on 16 Aug 2023, 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	18	18
SRD Part-Dose Group 1: BI 730357 PfOS 2 mg Fasted	6	6
SRD Part-Dose Group 2: BI 730357 PfOS 8 mg Fasted	6	6
SRD Part-Dose Group 3: BI 730357 Tablet 25 mg Fasted	6	6
SRD Part-Dose Group 4: BI 730357 Tablet 50 mg Fasted	6	6
SRD Part-Dose Group 5: BI 730357 Tablet(s) 100 mg Fasted	6	6
SRD Part-Dose Group 6: BI 730357 Tablet(s) 200 mg Fasted	6	6
SRD Part-Dose Group 7: BI 730357 Tablet(s) 400 mg Fasted	6	6
SRD Part-Dose Group 8-9: BI 730357 Tablet(s) 400 mg Fed	6	6
SRD Part-Dose Group 10: BI 730357 Tablet(s) 800 mg Fed	6	6
BA Part: R/T2/T1	2	2
BA Part: R/T1/T2	2	2
BA Part: T2/R/T1	2	2
BA Part: T2/T1/R	2	2
BA Part: T1/R/T2	2	2
BA Part: T1/T2/R	2	2

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

Time frame: SRD 1-7, 10: From first drug administration until end of trial (EOT), up to 13 days. SRD 8-9: From first drug administration until end of trial (EOT), up to 27 days. BA: From first drug administration until end of trial (EOT), up to 41 days.. Number. Unit: Percentage of participants

Measure	Placebo n = 18	SRD Part-Dose Group 1: BI 730357 PfOS 2 mg Fasted n = 6	SRD Part-Dose Group 2: BI 730357 PfOS 8 mg Fasted n = 6	SRD Part-Dose Group 3: BI 730357 Tablet 25 mg Fasted n = 6	SRD Part-Dose Group 4: BI 730357 Tablet 50 mg Fasted n = 6	SRD Part-Dose Group 5: BI 730357 Tablet(s) 100 mg Fasted n = 6	SRD Part-Dose Group 6: BI 730357 Tablet(s) 200 mg Fasted n = 6	SRD Part-Dose Group 7: BI 730357 Tablet(s) 400 mg Fasted n = 6	SRD Part-Dose Group 8: BI 730357 Tablets(s) 400 mg Fed1 n = 6	SRD Part-Dose Group 9: BI 730357 Tablets(s) 400 mg Fed2 n = 5	SRD Part-Dose Group 10: BI 730357 Tablet(s) 800 mg Fed n = 6	BA Part: BI 730357 Tablet 25 mg Fasted (R) n = 11	BA Part: BI 730357 PfOS 25 mg Fasted (T1) n = 12	BA Part: BI 730357 Tablet 25 mg Fed (T2) n = 12
Value	5.6	0.0	16.7	0.0	0.0	16.7	16.7	0.0	0.0	20.0	0.0	0.0	0.0	0.0

Population analysed: Treated set (TS): This subject set included all subjects from the Randomised set (RS) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: SRD 1-7, 9-10: From first drug administration until end of trial (EOT), up to 13 days. SRD 8: From first drug administration until end of trial (EOT), up to 14 days. BA per treatment: From first drug administration until end of trial (EOT), up to 14 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 18 (0%)	5 of 18 (27.8%)	0 of 18
SRD Part-Dose Group 1: BI 730357 PfOS 2 mg Fasted	0 of 6 (0%)	3 of 6 (50%)	0 of 6
SRD Part-Dose Group 2: BI 730357 PfOS 8 mg Fasted	0 of 6 (0%)	3 of 6 (50%)	0 of 6
SRD Part-Dose Group 3: BI 730357 Tablet 25 mg Fasted	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
SRD Part-Dose Group 4: BI 730357 Tablet 50 mg Fasted	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
SRD Part-Dose Group 5: BI 730357 Tablet(s) 100 mg Fasted	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
SRD Part-Dose Group 6: BI 730357 Tablet(s) 200 mg Fasted	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
SRD Part-Dose Group 7: BI 730357 Tablet(s) 400 mg Fasted	0 of 6 (0%)	3 of 6 (50%)	0 of 6
SRD Part-Dose Group 8: BI 730357 Tablets(s) 400 mg Fed1	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
SRD Part-Dose Group 9: BI 730357 Tablets(s) 400 mg Fed2	0 of 5 (0%)	3 of 5 (60%)	0 of 5
SRD Part-Dose Group 10: BI 730357 Tablet(s) 800 mg Fed	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
BA Part: BI 730357 Tablet 25 mg Fasted (R)	0 of 11 (0%)	2 of 11 (18.2%)	0 of 11
BA Part: BI 730357 PfOS 25 mg Fasted (T1)	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
BA Part: BI 730357 Tablet 25 mg Fed (T2)	0 of 12 (0%)	3 of 12 (25%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
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 730357 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 4 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 16 Aug 2023. 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 16 Aug 2023). 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: SRD 1-7, 10: From first drug administration until end of trial (EOT), up to 13 days. SRD 8-9: From first drug administration until end of trial (EOT), up to 27 days. BA: From first drug administration until end of trial (EOT), up to 41 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 NCT03004404.

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 16 Aug 2023.