Multiple Rising Oral Doses of BI 691751 in Healthy Male Subjects

NCT ID: NCT02148107

Last Updated: 2016-02-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-08-31

Brief Summary

It is the objective of this MRD trial to investigate pharmacokinetics, pharmcodynamics, safety and tolerability of rising doses BI 691751 over a treatment period of 14 days to support the further clinical development of this LTA4H-inhibitor. Special emphasis will be given to detect potential effects of BI 691751 on heart rate.

Conditions

Healthy

Study Design

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

Study Groups

BI 691751 Dose 1

multiple dose given over 14 days

Group Type: EXPERIMENTAL

BI 691751

Intervention Type: DRUG

BI 691751 Dose 1

BI 691751 Dose 2

multiple dose given over 14 days

Group Type: EXPERIMENTAL

BI 691751

Intervention Type: DRUG

BI 691751 Dose 2

BI 691751 Dose 3

multiple dose given over 14 days

Group Type: EXPERIMENTAL

BI 691751

Intervention Type: DRUG

BI 691751 Dose 3

BI 691751 Dose 4

multiple dose given over 14 days

Group Type: EXPERIMENTAL

BI 691751

Intervention Type: DRUG

BI 691751 Dose 4

BI 691751 Dose 5

multiple dose given over 14 days

Group Type: EXPERIMENTAL

BI 691751

Intervention Type: DRUG

BI 691751 Dose 5

BI 691751 Dose 6

multiple dose given over 14 days

Group Type: EXPERIMENTAL

BI 691751

Intervention Type: DRUG

BI 691751 Dose 6

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

BI 691751

BI 691751 Dose 1

Intervention Type: DRUG

BI 691751

BI 691751 Dose 2

Intervention Type: DRUG

BI 691751

BI 691751 Dose 3

Intervention Type: DRUG

BI 691751

BI 691751 Dose 4

Intervention Type: DRUG

BI 691751

BI 691751 Dose 5

Intervention Type: DRUG

BI 691751

BI 691751 Dose 6

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male subjects according to the investigator´s assessment, based on a complete medical history including a physical examination, vital signs (BP (blood pressure), PR (pulse rate), 12-lead ECG (electro cardiogramm), and clinical laboratory tests
• Age of 18 to 50 years (incl.)
• BMI (body mass index) of 18.5 to 29.9 kg/m2 (incl.)
• Signed and dated written informed consent prior to admission to the study in accordance with GCP(Good Clinical Practice) and local legislation
• Subject is able to understand and communicate in German

Exclusion Criteria

• Any finding in the medical examination (including BP (blood pressure), PR (pulse rate) or ECG (electro cardiogramm) is deviating from normal and judged as clinically relevant by the investigator
• Pulse rate outside 45-80 bpm (beats per minutes) or repeated measurement of systolic blood pressure greater than 140 mmHg, diastolic blood pressure greater than 90 mm Hg
• 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
• Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication
• Diseases of the central nervous system (such as epilepsy), other neurological disorders 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)
• Intake of drugs with a long half-life (more than 24 h) within 30 days or less than 10 half-lives of the respective drug prior to administration of trial medication
• Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial or that might prolong the QT/QTc interval
• Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication
• Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
• Inability to refrain from smoking during inhouse-confinement
• 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 in males) 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
• Vulnerable subjects, e.g. subjects kept in detention, soldiers, employees of the sponsor or a clinical research organization, involved in this study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1334.2.1 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Countries

Germany

Other Identifiers

2013-003813-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1334.2

Identifier Type: -

Identifier Source: org_study_id