Multiple Rising Oral Doses of BI 691751 in Healthy Male Subjects

Boehringer Ingelheim

Status and phase

Terminated

Phase 1

Conditions

Healthy

Treatments

Drug: Placebo

Drug: BI 691751

Study type

Interventional

Funder types

Industry

Identifiers

NCT02148107

2013-003813-17 (EudraCT Number)

1334.2

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

18 participants in 7 patient groups, including a placebo group

BI 691751 Dose 1

Experimental group

Description: