This Study in Healthy Men Tests How Different Doses of BI 894416 Are Taken up in the Body and How Well BI 894416 is Tolerated

NCT ID: NCT03315936

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-02
• Study Completion Date: 2018-09-10

Brief Summary

This first-in man trial is designed to investigate the safety and tolerability of BI 894416 in healthy male subjects following oral administration of single rising doses.

Pharmacokinetics (PK) including dose proportionality after single dosing of BI 894416 as oral solution will be explored, the investigation of PK of BI 894416 as tablet formulation and the exploration of relative bioavailability of BI 894416 as tablet formulation compared to oral solution.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Placebo matching BI 894416 (SRD Part)

Single Rising Dose (SRD) Part

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral solution

BI 894416 3 milligram (mg)

SRD Part

Group Type: EXPERIMENTAL

BI 894416

Intervention Type: DRUG

powder for oral solution

BI 894416 10 mg

SRD Part

Group Type: EXPERIMENTAL

BI 894416

Intervention Type: DRUG

powder for oral solution

BI 894416 20 mg

SRD Part

Group Type: EXPERIMENTAL

BI 894416

Intervention Type: DRUG

powder for oral solution

BI 894416 30 mg

SRD Part

Group Type: EXPERIMENTAL

BI 894416

Intervention Type: DRUG

powder for oral solution

BI 894416 40 mg

SRD Part

Group Type: EXPERIMENTAL

BI 894416

Intervention Type: DRUG

powder for oral solution

BI 894416 54 mg

SRD Part

Group Type: EXPERIMENTAL

BI 894416

Intervention Type: DRUG

powder for oral solution

BI 894416 70 mg

SRD Part

Group Type: EXPERIMENTAL

BI 894416

Intervention Type: DRUG

powder for oral solution

BI 894416 10mg tb / 10mg PfOS / 40mg tb

BI 894416 10 mg tablet (tb) / BI 894416 10 mg powder for oral solution (PfOS) / BI 894416 4*10 mg tablets.

Relative bioavailability (rel BA) part

Group Type: EXPERIMENTAL

BI 894416

Intervention Type: DRUG

powder for oral solution

BI 894416

Intervention Type: DRUG

Tablet

BI 894416 10mg PfOS / 10mg tb / 40mg tb

BI 894416 10 mg powder for oral solution (PfOS) / BI 894416 10 mg tablet (tb) / BI 894416 4*10 mg tablets.

Relative bioavailability (rel BA) part.

Group Type: EXPERIMENTAL

BI 894416

Intervention Type: DRUG

powder for oral solution

BI 894416

Intervention Type: DRUG

Tablet

Interventions

BI 894416

powder for oral solution

Intervention Type: DRUG

Placebo

Oral solution

Intervention Type: DRUG

BI 894416

Tablet

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male subjects according to the assessment of the investigator, 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

Exclusion Criteria

• Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG) and including the neurological examination) 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)
• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
• History of relevant orthostatic hypotension, fainting spells, or blackouts
• Chronic or relevant acute infections
• History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
• Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
• Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug
• Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
• Inability to refrain from smoking on specified trial days
• Alcohol abuse (consumption of more than 30 g per day)
• Drug abuse or positive drug screening
• Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial
• Intention to perform excessive physical activities within 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

• 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)
• 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)
• 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 administration of trial medication until 30 days thereafter.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Humanpharmakologisches Zentrum Biberach

Biberach, , Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.mystudywindow.com

Related Info

Other Identifiers

2016-003470-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1371-0001

Identifier Type: -

Identifier Source: org_study_id