HealthyPhase 1NCT04232839

A Study in Healthy Men to Find the Best Formulation of BI 894416 and to Test How This is Taken up in the Body

A Phase 1 study testing BI 894416 Reference Formulation, BI 894416 Formulation A2 and BI 894416 Formulation C2 in people with Healthy, run by Boehringer Ingelheim at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The main objective of this trial is to select a formulation principle (tablet vs. capsule) and to optimize the identified extended release formulation of BI 894416, if needed. 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
What is being tested?: BI 894416 Reference Formulation, BI 894416 Formulation A2 and BI 894416 Formulation C2
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited Kingdom
Study dates: 25 Feb 2020to 30 Nov 2020
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 assessment of the investigator, as 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 (inclusive) at the time of signing informed consent
Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive) as measured at screening
Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
Subjects who are sexually active must use, with their partner, highly effective contraception from the time of administration of trial medication until 30 days after administration of trial medication. Adequate methods are:
Condoms plus use of hormonal contraception by the female partner that started at least 2 months prior to administration of trial medication (e.g., implants, injectables, combined oral or vaginal contraceptives, intrauterine device) or

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Condoms plus surgical sterilization (vasectomy at least 1 year prior to enrolment) or
Condoms plus surgically sterilised partner (including hysterectomy) or
Condoms plus intrauterine device or
Condoms plus partner of non-childbearing potential (including homosexual men) Subjects are required to use condoms to prevent unintended exposure of the partner (both, male and female) to the study drug via seminal fluid. Male subjects should use a condom throughout the study and for 30 days after last Investigational Medicinal Product (IMP) administration. Alternatively, true abstinence is acceptable when it is in line with the subject's preferred and usual lifestyle. If a subject is usually not sexually active but becomes active, with their partner, they must comply with the contraceptive requirements detailed above Male subjects should not donate sperm for the duration of the study and for at least 30 days after last IMP administration

Who cannot join

Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR), Electrocardiogram (ECG), physical and neurological examination) deviating from normal and assessed 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 40 to 90 mmHg, or pulse rate outside the range of 40 to 100 bpm at screening and pre-dose of first period
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease assessed as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or 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). Inactive hayfever is permitted.
Use of drugs within 30 days of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation)
Intake of an investigational drug in another clinical trial within 90 days of planned first administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered
Smoker (unless the subject quit smoking for at least 3 months prior to first planned administration of trial medication) as demonstrated by a positive urine cotinine test; this includes also the use of e-cigarettes and nicotine replacement products
Alcohol abuse (consumption of more than 21 units per week) or positive alcohol breath test
Drug abuse or positive drug screening
Blood donation of more than 100 mL within 30 days of planned administration of trial medication or intended blood donation during the trial
Intention to perform excessive physical activities within one week prior to the administration of trial medication or during the trial
Inability to comply with the dietary regimen of the 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 and predose
A history of additional risk factors for Torsade 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 the subject is not considered able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
History of relevant neurological disorder affecting the peripheral or central nervous system (this includes but is not limited to: stroke, epilepsy, inflammatory or atrophic diseases affecting the nervous system, cluster headache or any cancer of the nervous system). Febrile seizures in childhood or adolescence, recovered carpal tunnel syndrome, recovered uncomplicated meningitis, recovered herpes zoster, tension headache, occasional benign tics (e.g. due to stress) or minor par- or dysesthesia (e.g. as a side effect of prior blood withdrawal) do not constitute a history of relevant neurological disorder.
History of immunological disease, except allergy not relevant to the trial (such as mild hay fever or dust mite allergy) and except asthma in childhood or adolescence
History of cancer (other than successfully treated basal cell carcinoma)
Liver enzymes (ALT, AST, GGT, AP) above upper limit of normal at the screening examination
Within 10 days prior to administration of trial medication, use of any drug that could reasonably inhibit platelet aggregation or coagulation (e.g., acetylsalicylic acid)
Male subjects with Woman of child bearing potential (WOCBP) partner who are unwilling to use male contraception (condom or sexual abstinence) from time point of first administration of trial medication until 30 days after the last administration of trial medication
Subjects with pregnant or lactating partners

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Quotient Sciences
Nottingham, NG11 6JS

Other trials in United Kingdom

About this study

Official title: Formulation Selection and Subsequent Optimization of Two Different Oral Formulations of BI 894416 in Healthy Male Subjects (Open-label, Randomised, Single-dose Study in Two Parts; Trial Part 1: Five-period Crossover Design With an Additional Sixth Period in a Fixed Sequence; Trial Part 2: Three-period Crossover Followed by a Two-period Crossover Design)

The main objective of this trial is to select a formulation principle (tablet vs. capsule) and to optimize the identified extended release formulation of BI 894416, if needed.

Conditions: Healthy
Being tested: BI 894416 Reference Formulation, BI 894416 Formulation A2, BI 894416 Formulation C2, BI 894416 Formulation D2, BI 894416 Formulation F2

What participants receive

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

BI 894416 Reference FormulationDrug
R1 - 60 milligram (6 x 10 milligram tablets) BI 894416 Reference Formulation, immediate release (IR) tablets taken orally with 240 mL of water after an overnight fast of at least 10 hours.
BI 894416 Formulation A2Drug
T1 - One single dose of 62.5 milligram (1 tablet) BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR) taken orally with 240 mL of water after an overnight fast of at least 10 hours.
BI 894416 Formulation C2Drug
T2 - One single dose of 62.5 milligram (1 tablet) BI 894416 Formulation C2, extended release (ER) tablet (slow release rate, SRR) taken orally with 240 mL of water after an overnight fast of at least 10 hours.
and T5 - One single dose of 62.5 milligram (1 tablet) BI 894416 Formulation C2, extended release (ER) tablet (slow release rate, SRR) taken orally with 240 mL of water following a high-fat high-calorie breakfast.
BI 894416 Formulation D2Drug
T3 - One single dose of 62.5 milligram (1 capsule) BI 894416 Formulation D2, extended release (ER) capsule (fast release rate, FRR) taken orally with 240 mL of water after an overnight fast of at least 10 hours.
BI 894416 Formulation F2Drug
T4 - One single dose of 62.5 milligram (1 capsule) BI 894416 Formulation F2, extended release (ER) capsule (slow release rate, SRR) taken orally with 240 mL of water after an overnight fast of at least 10 hours.
and T6 - One single dose of 62.5 milligram (1 capsule) BI 894416 Formulation F2, extended release (ER) capsule (slow release rate, SRR) taken orally with 240 mL of water following a high-fat high-calorie breakfast.

Study groups in NCT04232839
Study group	Role	What they receive
T3-R1-T1-T4-T2-T5 (sequence I+T5)	Experimental	Sequence I+T5, with treatments in the following order: T3-R1-T1-T4-T2-T5 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Receives: Drug: BI 894416 Reference Formulation; Drug: BI 894416 Formulation A2; Drug: BI 894416 Formulation C2; Drug: BI 894416 Formulation D2; Drug: BI 894416 Formulation F2
T3-R1-T1-T4-T2-T6 (sequence I+T6)	Experimental	Sequence I+T6, with treatments in the following order: T3-R1-T1-T4-T2-T6 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Receives: Drug: BI 894416 Reference Formulation; Drug: BI 894416 Formulation A2; Drug: BI 894416 Formulation C2; Drug: BI 894416 Formulation D2; Drug: BI 894416 Formulation F2
T2-T1-T3-R1-T4-T5 (sequence II+T5)	Experimental	Sequence II+T5, with treatments in the following order: T2-T1-T3-R1-T4-T5with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Receives: Drug: BI 894416 Reference Formulation; Drug: BI 894416 Formulation A2; Drug: BI 894416 Formulation C2; Drug: BI 894416 Formulation D2; Drug: BI 894416 Formulation F2
T2-T1-T3-R1-T4-T6 (sequence II+T6)	Experimental	Sequence II+T6, with treatments in the following order: T2-T1-T3-R1-T4-T6 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Receives: Drug: BI 894416 Reference Formulation; Drug: BI 894416 Formulation A2; Drug: BI 894416 Formulation C2; Drug: BI 894416 Formulation D2; Drug: BI 894416 Formulation F2
T4-T3-R1-T2-T1-T5 (sequence III+T5)	Experimental	Sequence III+T5, with treatments in the following order: T4-T3-R1-T2-T1-T5 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Receives: Drug: BI 894416 Reference Formulation; Drug: BI 894416 Formulation A2; Drug: BI 894416 Formulation C2; Drug: BI 894416 Formulation D2; Drug: BI 894416 Formulation F2
T4-T3-R1-T2-T1-T6 (sequence III+T6)	Experimental	Sequence III+T6, with treatments in the following order: T4-T3-R1-T2-T1-T6 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Receives: Drug: BI 894416 Reference Formulation; Drug: BI 894416 Formulation A2; Drug: BI 894416 Formulation C2; Drug: BI 894416 Formulation D2; Drug: BI 894416 Formulation F2
T1-T4-T2-T3-R1-T5 (sequence IV+T5)	Experimental	Sequence IV+T5, with treatments in the following order: T1-T4-T2-T3-R1-T5 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Receives: Drug: BI 894416 Reference Formulation; Drug: BI 894416 Formulation A2; Drug: BI 894416 Formulation C2; Drug: BI 894416 Formulation D2; Drug: BI 894416 Formulation F2
T1-T4-T2-T3-R1-T6 (sequence IV+T6)	Experimental	Sequence IV+T6, with treatments in the following order: T1-T4-T2-T3-R1-T6 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Receives: Drug: BI 894416 Reference Formulation; Drug: BI 894416 Formulation A2; Drug: BI 894416 Formulation C2; Drug: BI 894416 Formulation D2; Drug: BI 894416 Formulation F2
R1-T2-T4-T1-T3-T5 (sequence V+T5)	Experimental	Sequence V+T5, with treatments in the following order: R1-T2-T4-T1-T3-T5 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Receives: Drug: BI 894416 Reference Formulation; Drug: BI 894416 Formulation A2; Drug: BI 894416 Formulation C2; Drug: BI 894416 Formulation D2; Drug: BI 894416 Formulation F2
R1-T2-T4-T1-T3-T6 (sequence V+T6)	Experimental	Sequence V+T6, with treatments in the following order: R1-T2-T4-T1-T3-T6with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Receives: Drug: BI 894416 Reference Formulation; Drug: BI 894416 Formulation A2; Drug: BI 894416 Formulation C2; Drug: BI 894416 Formulation D2; Drug: BI 894416 Formulation F2

What is being measured

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

Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of BI 894416 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Measured: Within 3 hours before and 0.33, 0.66, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 34, 48, 58 and 72 hours following drug administration.

Secondary outcomes (1)

Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of BI 894416 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
Measured: Within 3 hours before and 0.33, 0.66, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 34, 48, 58 and 72 hours following drug administration.

Timeline

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

25 Feb 202030 Nov 2020

First posted18 Jan 2020
Study start25 Feb 2020
Primary completion30 Nov 2020
Study completion30 Nov 2020

Why it stopped: Due to company decision.

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: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04232839
Sponsor's protocol ID: 1371-0022
Other IDs: 2019-003424-21, 2019
Status last verified: Apr 2024
First submitted: 15 Jan 2020
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
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, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).For more details refer to: http://trials.boehringer-ingelheim.com/

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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Formulation Selection and Subsequent Optimization of Two Different Oral Formulations of BI 894416 in Healthy Male Subjects (Open-label, Randomised, Single-dose Study in Two Parts; Trial Part 1: Five-period Crossover Design With an Additional Sixth Period in a Fixed Sequence; Trial Part 2: Three-period Crossover Followed by a Two-period Crossover Design)
ClinicalTrials.gov ID: NCT04232839
Acronym / sponsor ID: 1371-0022
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to company decision.
Enrolment: 24 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 25 Feb 2020 (actual)
Primary completion: 30 Nov 2020 (actual)
Study completion: 30 Nov 2020 (actual)
First posted: 18 Jan 2020 (actual)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main objective of this trial is to select a formulation principle (tablet vs. capsule) and to optimize the identified extended release formulation of BI 894416, if needed.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 10

Arm	Type	Receives
T3-R1-T1-T4-T2-T5 (sequence I+T5)	Experimental	Drug: BI 894416 Reference Formulation, Drug: BI 894416 Formulation A2, Drug: BI 894416 Formulation C2, Drug: BI 894416 Formulation D2, Drug: BI 894416 Formulation F2Sequence I+T5, with treatments in the following order: T3-R1-T1-T4-T2-T5 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
T3-R1-T1-T4-T2-T6 (sequence I+T6)	Experimental	Drug: BI 894416 Reference Formulation, Drug: BI 894416 Formulation A2, Drug: BI 894416 Formulation C2, Drug: BI 894416 Formulation D2, Drug: BI 894416 Formulation F2Sequence I+T6, with treatments in the following order: T3-R1-T1-T4-T2-T6 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
T2-T1-T3-R1-T4-T5 (sequence II+T5)	Experimental	Drug: BI 894416 Reference Formulation, Drug: BI 894416 Formulation A2, Drug: BI 894416 Formulation C2, Drug: BI 894416 Formulation D2, Drug: BI 894416 Formulation F2Sequence II+T5, with treatments in the following order: T2-T1-T3-R1-T4-T5with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
T2-T1-T3-R1-T4-T6 (sequence II+T6)	Experimental	Drug: BI 894416 Reference Formulation, Drug: BI 894416 Formulation A2, Drug: BI 894416 Formulation C2, Drug: BI 894416 Formulation D2, Drug: BI 894416 Formulation F2Sequence II+T6, with treatments in the following order: T2-T1-T3-R1-T4-T6 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
T4-T3-R1-T2-T1-T5 (sequence III+T5)	Experimental	Drug: BI 894416 Reference Formulation, Drug: BI 894416 Formulation A2, Drug: BI 894416 Formulation C2, Drug: BI 894416 Formulation D2, Drug: BI 894416 Formulation F2Sequence III+T5, with treatments in the following order: T4-T3-R1-T2-T1-T5 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
T4-T3-R1-T2-T1-T6 (sequence III+T6)	Experimental	Drug: BI 894416 Reference Formulation, Drug: BI 894416 Formulation A2, Drug: BI 894416 Formulation C2, Drug: BI 894416 Formulation D2, Drug: BI 894416 Formulation F2Sequence III+T6, with treatments in the following order: T4-T3-R1-T2-T1-T6 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
T1-T4-T2-T3-R1-T5 (sequence IV+T5)	Experimental	Drug: BI 894416 Reference Formulation, Drug: BI 894416 Formulation A2, Drug: BI 894416 Formulation C2, Drug: BI 894416 Formulation D2, Drug: BI 894416 Formulation F2Sequence IV+T5, with treatments in the following order: T1-T4-T2-T3-R1-T5 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
T1-T4-T2-T3-R1-T6 (sequence IV+T6)	Experimental	Drug: BI 894416 Reference Formulation, Drug: BI 894416 Formulation A2, Drug: BI 894416 Formulation C2, Drug: BI 894416 Formulation D2, Drug: BI 894416 Formulation F2Sequence IV+T6, with treatments in the following order: T1-T4-T2-T3-R1-T6 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
R1-T2-T4-T1-T3-T5 (sequence V+T5)	Experimental	Drug: BI 894416 Reference Formulation, Drug: BI 894416 Formulation A2, Drug: BI 894416 Formulation C2, Drug: BI 894416 Formulation D2, Drug: BI 894416 Formulation F2Sequence V+T5, with treatments in the following order: R1-T2-T4-T1-T3-T5 with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).
R1-T2-T4-T1-T3-T6 (sequence V+T6)	Experimental	Drug: BI 894416 Reference Formulation, Drug: BI 894416 Formulation A2, Drug: BI 894416 Formulation C2, Drug: BI 894416 Formulation D2, Drug: BI 894416 Formulation F2Sequence V+T6, with treatments in the following order: R1-T2-T4-T1-T3-T6with a washout period of at least 4 days between treatments. All test treatments (T1-T6) were one single dose of 62.5 milligram. R1 and T1-T4: taken orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours. T5-T6: taken orally with 240 mL of water following a high-fat high-calorie breakfast. Reference (R1): 60 milligram (mg) (6 x 10 mg tablets) BI 894416 Reference Formulation, immediate release (IR) tablets. Test 1 (T1): 1 tablet BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR). Test 2 (T2): 1 tablet BI 894416 Formulation C2, ER tablet (slow release rate, SRR). Test 3 (T3): 1 capsule BI 894416 Formulation D2, ER capsule (FRR). Test 4 (T4): 1 capsule BI 894416 Formulation F2, ER capsule (SRR). Test 5 (T5): 1 tablet BI 894416 Formulation C2, ER tablet (SRR). Test 6 (T6): 1 capsule BI 894416 Formulation F2, ER capsule (SRR).

Who may qualify

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

Key inclusion criteria (10 listed)

Healthy male subjects according to the assessment of the investigator, as 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 (inclusive) at the time of signing informed consent
Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive) as measured at screening
Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
Subjects who are sexually active must use, with their partner, highly effective contraception from the time of administration of trial medication until 30 days after administration of trial medication. Adequate methods are:

Key exclusion criteria (28 listed)

Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR), Electrocardiogram (ECG), physical and neurological examination) deviating from normal and assessed 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 40 to 90 mmHg, or pulse rate outside the range of 40 to 100 bpm at screening and pre-dose of first period
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease assessed 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 894416 Reference FormulationR1 - 60 milligram (6 x 10 milligram tablets) BI 894416 Reference Formulation, immediate release (IR) tablets taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Drug	R1-T2-T4-T1-T3-T5 (sequence V+T5), R1-T2-T4-T1-T3-T6 (sequence V+T6), T1-T4-T2-T3-R1-T5 (sequence IV+T5), T1-T4-T2-T3-R1-T6 (sequence IV+T6), T2-T1-T3-R1-T4-T5 (sequence II+T5), T2-T1-T3-R1-T4-T6 (sequence II+T6), T3-R1-T1-T4-T2-T5 (sequence I+T5), T3-R1-T1-T4-T2-T6 (sequence I+T6), T4-T3-R1-T2-T1-T5 (sequence III+T5), T4-T3-R1-T2-T1-T6 (sequence III+T6)
BI 894416 Formulation A2T1 - One single dose of 62.5 milligram (1 tablet) BI 894416 Formulation A2, extended release (ER) tablet (fast release rate, FRR) taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Drug	R1-T2-T4-T1-T3-T5 (sequence V+T5), R1-T2-T4-T1-T3-T6 (sequence V+T6), T1-T4-T2-T3-R1-T5 (sequence IV+T5), T1-T4-T2-T3-R1-T6 (sequence IV+T6), T2-T1-T3-R1-T4-T5 (sequence II+T5), T2-T1-T3-R1-T4-T6 (sequence II+T6), T3-R1-T1-T4-T2-T5 (sequence I+T5), T3-R1-T1-T4-T2-T6 (sequence I+T6), T4-T3-R1-T2-T1-T5 (sequence III+T5), T4-T3-R1-T2-T1-T6 (sequence III+T6)
BI 894416 Formulation C2T2 - One single dose of 62.5 milligram (1 tablet) BI 894416 Formulation C2, extended release (ER) tablet (slow release rate, SRR) taken orally with 240 mL of water after an overnight fast of at least 10 hours. and T5 - One single dose of 62.5 milligram (1 tablet) BI 894416 Formulation C2, extended release (ER) tablet (slow release rate, SRR) taken orally with 240 mL of water following a high-fat high-calorie breakfast.	Drug	R1-T2-T4-T1-T3-T5 (sequence V+T5), R1-T2-T4-T1-T3-T6 (sequence V+T6), T1-T4-T2-T3-R1-T5 (sequence IV+T5), T1-T4-T2-T3-R1-T6 (sequence IV+T6), T2-T1-T3-R1-T4-T5 (sequence II+T5), T2-T1-T3-R1-T4-T6 (sequence II+T6), T3-R1-T1-T4-T2-T5 (sequence I+T5), T3-R1-T1-T4-T2-T6 (sequence I+T6), T4-T3-R1-T2-T1-T5 (sequence III+T5), T4-T3-R1-T2-T1-T6 (sequence III+T6)
BI 894416 Formulation D2T3 - One single dose of 62.5 milligram (1 capsule) BI 894416 Formulation D2, extended release (ER) capsule (fast release rate, FRR) taken orally with 240 mL of water after an overnight fast of at least 10 hours.	Drug	R1-T2-T4-T1-T3-T5 (sequence V+T5), R1-T2-T4-T1-T3-T6 (sequence V+T6), T1-T4-T2-T3-R1-T5 (sequence IV+T5), T1-T4-T2-T3-R1-T6 (sequence IV+T6), T2-T1-T3-R1-T4-T5 (sequence II+T5), T2-T1-T3-R1-T4-T6 (sequence II+T6), T3-R1-T1-T4-T2-T5 (sequence I+T5), T3-R1-T1-T4-T2-T6 (sequence I+T6), T4-T3-R1-T2-T1-T5 (sequence III+T5), T4-T3-R1-T2-T1-T6 (sequence III+T6)
BI 894416 Formulation F2T4 - One single dose of 62.5 milligram (1 capsule) BI 894416 Formulation F2, extended release (ER) capsule (slow release rate, SRR) taken orally with 240 mL of water after an overnight fast of at least 10 hours. and T6 - One single dose of 62.5 milligram (1 capsule) BI 894416 Formulation F2, extended release (ER) capsule (slow release rate, SRR) taken orally with 240 mL of water following a high-fat high-calorie breakfast.	Drug	R1-T2-T4-T1-T3-T5 (sequence V+T5), R1-T2-T4-T1-T3-T6 (sequence V+T6), T1-T4-T2-T3-R1-T5 (sequence IV+T5), T1-T4-T2-T3-R1-T6 (sequence IV+T6), T2-T1-T3-R1-T4-T5 (sequence II+T5), T2-T1-T3-R1-T4-T6 (sequence II+T6), T3-R1-T1-T4-T2-T5 (sequence I+T5), T3-R1-T1-T4-T2-T6 (sequence I+T6), T4-T3-R1-T2-T1-T5 (sequence III+T5), T4-T3-R1-T2-T1-T6 (sequence III+T6)

Primary outcome

Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Within 3 hours before and 0.33, 0.66, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 34, 48, 58 and 72 hours following drug administration.
Area under the concentration-time curve of BI 894416 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).

1 secondary outcome

Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: Within 3 hours before and 0.33, 0.66, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 34, 48, 58 and 72 hours following drug administration.

Results and safety

Results posted to the registry on 19 Sep 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
T3-R1-T1-T4-T2-T5 (Sequence I+T5)	2	2
T3-R1-T1-T4-T2-T6 (Sequence I+T6)	2	2
T2-T1-T3-R1-T4-T5 (Sequence II+T5)	2	2
T2-T1-T3-R1-T4-T6 (Sequence II+T6)	3	3
T4-T3-R1-T2-T1-T5 (Sequence III+T5)	2	2
T4-T3-R1-T2-T1-T6 (Sequence III+T6)	2	2
T1-T4-T2-T3-R1-T5 (Sequence IV+T5)	3	3
T1-T4-T2-T3-R1-T6 (Sequence IV+T6)	3	3
R1-T2-T4-T1-T3-T5 (Sequence V+T5)	2	2
R1-T2-T4-T1-T3-T6 (Sequence V+T6)	3	3

Primary outcome: Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

Time frame: Within 3 hours before and 0.33, 0.66, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 34, 48, 58 and 72 hours following drug administration.. Geometric mean (Geometric Coefficient of Variation). Unit: hour*nanomol/Liter

Measure	Reference 1 - BI 894416 Reference Formulation Tablet, Fasted n = 24	Test 1 - BI 894416 Fast Release Rate (FRR) Tablet, Fasted n = 24	Test 2 - BI 894416 Slow Release Rate (SRR) Tablet, Fasted n = 24	Test 3 - BI 894416 Fast Release Rate (FRR) Capsule, Fasted n = 24	Test 4 - BI 894416 Slow Release Rate (SRR) Capsule, Fasted n = 24	Test 5 - BI 894416 Slow Release Rate (SRR) Tablet, Fed n = 11	Test 6 - BI 894416 Slow Release Rate (SRR) Capsule, Fed n = 13
Value	9800 (30.6)	8260 (29.6)	7030 (31.7)	9100 (33.3)	7430 (35.8)	9680 (31.1)	8930 (24.8)

Reference 1 - BI 894416 Reference Formulation Tablet, Fasted vs Test 1 - BI 894416 Fast Release Rate (FRR) Tablet, Fasted: Adjusted geometric mean (gMean) ratio(%): 85.9 (90% CI 80.3 to 91.7)
Reference 1 - BI 894416 Reference Formulation Tablet, Fasted vs Test 2 - BI 894416 Slow Release Rate (SRR) Tablet, Fasted: Adjusted geometric mean (gMean) ratio(%): 72.6 (90% CI 68.0 to 77.6)
Reference 1 - BI 894416 Reference Formulation Tablet, Fasted vs Test 3 - BI 894416 Fast Release Rate (FRR) Capsule, Fasted: Adjusted geometric mean (gMean) ratio(%): 92.4 (90% CI 86.5 to 98.8)

Population analysed: Pharmacokinetic (PK) parameter analysis set (PKS): This analysis set included all subjects who were randomised, received at least one dose of trial medication and who provided at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From the first administration of BI 894416 in any formulation until the subject's trial termination date, up to days 35 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Reference 1 - BI 894416 Reference Formulation Tablet, Fasted	0 of 24 (0%)	1 of 24 (4.2%)	0 of 24
Test 1 - BI 894416 Fast Release Rate (FRR) Tablet, Fasted	0 of 24 (0%)	1 of 24 (4.2%)	0 of 24
Test 2 - BI 894416 Slow Release Rate (SRR) Tablet, Fasted	0 of 24 (0%)	3 of 24 (12.5%)	0 of 24
Test 3 - BI 894416 Fast Release Rate (FRR) Capsule, Fasted	0 of 24 (0%)	2 of 24 (8.3%)	0 of 24
Test 4 - BI 894416 Slow Release Rate (SRR) Capsule, Fasted	0 of 24 (0%)	2 of 24 (8.3%)	0 of 24
Test 5 - BI 894416 Slow Release Rate (SRR) Tablet, Fed	0 of 11 (0%)	3 of 11 (27.3%)	0 of 11
Test 6 - BI 894416 Slow Release Rate (SRR) Capsule, Fed	0 of 13 (0%)	2 of 13 (15.4%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 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, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).For more details refer to: http://trials.boehringer-ingelheim.com/

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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.

The record lists no contact. Use the official record to reach the sponsor.

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 894416 Reference Formulation, BI 894416 Formulation A2 and BI 894416 Formulation C2 in people with Healthy, run by Boehringer Ingelheim at 1 site in United Kingdom.

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 10 inclusion and 28 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: stopped early, as of the sponsor's last update on 19 Sep 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 United Kingdom. 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 19 Sep 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?

Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (time frame: Within 3 hours before and 0.33, 0.66, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 34, 48, 58 and 72 hours following drug administration.). 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 NCT04232839.

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 19 Sep 2024.