Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 60732 in Healthy Male Volunteers

NCT ID: NCT02244203

Last Updated: 2014-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28

Brief Summary

Single Rising Dose (SRD) study: First evaluation of safety, tolerability, pharmacokinetics and pharmacodynamics of BI 60732

Conditions

Healthy

Study Design

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

Study Groups

Single rising doses of BI 60732

Group Type: EXPERIMENTAL

BI 60732

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

BI 60732

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
• Age ≥ 18 and Age ≤ 45 years
• BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice and the local legislation

Exclusion Criteria

• Any finding of the medical examination deviating from normal and of clinical relevance. Repeated measurement of a systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• Intake of drugs within one month or less than 10 half-lives of the respective drug prior to first study drug administration except if a relevant interaction can be ruled out
• Participation in another trial with an investigational drug within 2 months prior to first study drug administration
• Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
• Alcohol abuse (average consumption of more than 30 g / day)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to the start of study)
• Any laboratory value outside the reference range that is of clinical relevance
• Inability to comply with dietary regimen of trial site
• A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
• A history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)
• Anaemia at screening
• Subjects who in the investigator's judgement are perceived as having an increased risk of bleeding, for example because of:

• Hemorrhagic disorders or bleeding diathesis
• Occult blood in faeces or haematuria
• Trauma or surgery within the last month or as long as an excessive risk of bleeding persists after these events, or planned surgery during trial participation
• History of arteriovenous malformation or aneurysm
• History of gastroduodenal ulcer disease or gastrointestinal haemorrhage
• History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intraarticular bleeding
• Use of drugs that may interfere with haemostasis during trial conduct (e.g. acetylsalicylic acid or other non-steroidal anti-inflammatory drugs)
• Thrombocytopenia (platelet count < 100/nL)

• 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

Other Identifiers

1267.1

Identifier Type: -

Identifier Source: org_study_id