A Study in Healthy Men to Find Out How Well Different Doses of BI 764122 Are Tolerated and Whether Food Affects the Amount of BI 764122 in the Blood

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 764122; Drug: Placebo

• Registration Number: NCT03794323
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 764122 in healthy male subjects following oral administration of single rising doses.

The objective of the food effect (FE) part is to investigate the relative bioavailability of BI 764122 under fed and fasted conditions.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-01-04
• Study First Submitted QC: 2019-01-04
• Study First Posted: 2019-01-07
• Study Start: 2019-01-30
• Primary Completion: 2019-08-12
• Study Completion: 2019-08-12
• Status Verified: 2022-06
• Results First Submitted: 2022-06-30
• Results First Submitted QC: 2022-06-30
• Last Update Submitted: 2022-06-30
• Results First Posted: 2023-05-01
• Last Update Posted: 2023-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 76

Inclusion Criteria

• 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 50 years (inclusive)

• Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)

• Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation

• Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:

  • Use of adequate contraception, e.g. use of condom (male subjects) plus any of the following methods (female partners): intrauterine device, hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration to the male subject, or barrier method (e.g. diaphragm with spermicide), or surgically sterilised (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy), or postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with FSH above 40 U/L and estradiol below 30 ng/L)
  • Sexually abstinent
  • Vasectomised (vasectomy at least 1 year prior to enrolment) in combination with a barrier method (e.g. condom) Unprotected sexual intercourse with a pregnant female partner and sperm donation is not allowed throughout the study and until 30 days after trial completion.

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Exclusion Criteria

• Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) 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 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
• 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)
• 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 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 60 days of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered
• 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 as per investigator judgment 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
• 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

In addition, the following trial-specific exclusion criteria apply:

• History of acute pancreatitis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SRD part: BI 764122 300 mg	BI 764122	3 film-coated tablets of 100 mg BI 764122 (total: 300 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
SRD part: BI 764122 12 mg	BI 764122	1 film-coated tablet of 10 mg and 2 uncoated tablets of 1 mg BI 764122 (total: 12 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
SRD part: BI 764122 400 mg	BI 764122	4 film-coated tablets of 100 mg BI 764122 (total: 400 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
SRD part: BI 764122 50 mg	BI 764122	5 film-coated tablets of 10 mg BI 764122 (total 50 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
FE part: BI 764122 50 mg fasted/ BI 764122 50 mg fed	BI 764122	5 film-coated tablets of 10 mg BI 764122 (total: 50 mg) were administered as single oral dose with 240 mL water after an overnight fast of at least 10 h, followed by wash-out period of at least 7 days followed by 5 film-coated tablets of 10 mg BI 764122 (total: 50 mg) administered as single oral dose with 240 mL water after a standardized high-fat, high-calorie breakfast. Food effect (FE) part.
FE part: BI 764122 50 mg fed/ BI 764122 50 mg fasted	BI 764122	5 film-coated tablets of 10 mg BI 764122 (total: 50 mg) were administered as single oral dose with 240 mL water after a standardized high-fat, high-calorie breakfast, followed by wash-out period of at least 7 days followed by 5 film-coated tablets of 10 mg BI 764122 (total: 50 mg) administered as single oral dose with 240 mL water after an overnight fast of at least 10 h. FE part.
Placebo	Placebo	placebo matching in size and weight to corresponding uncoated or film-coated BI 764122 tablets were administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). Single rising dose (SRD) part.
SRD part: BI 764122 4 mg	BI 764122	4 uncoated tablets of 1 milligram (mg) BI 764122 (total: 4 mg) were administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). Single rising dose (SRD) part.
SRD part: BI 764122 25 mg	BI 764122	2 film-coated tablets of 10 mg and 5 uncoated tablets of 1 mg BI 764122 (total: 25 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
SRD part: BI 764122 100 mg	BI 764122	1 film-coated tablet of 100 mg BI 764122 (total: 100 mg) was administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
SRD part: BI 764122 200 mg	BI 764122	2 film-coated tablets of 100 mg BI 764122 (total: 200 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Drug-related Adverse Events	From drug administration until 11 days thereafter for both single rising doses and food effect parts.	Percentage of subjects with drug-related adverse events.

Secondary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve of BI 764122 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)	Within 30 minutes (min) before and 10, 20, 30, 45min and 1 hour (h), 1h 30min, 2, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 96 and 120 h post administration.	Area under the concentration-time curve of BI 764122 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).
Maximum Measured Concentration of BI 764122 in Plasma (Cmax)	Within 30 minutes (min) before and 10, 20, 30, 45min and 1 hour (h), 1h 30min, 2, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 96 and 120 h post administration.	Maximum measured concentration of BI 764122 in plasma (Cmax).

Trial Locations

Locations (1)

SGS Life Science Services - Clinical Research; 🇧🇪 Edegem, Belgium