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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: BI 60732

Study type: Interventional

Funder types: Industry

Identifiers

NCT02244203

1267.1

Details and patient eligibility

About

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

Enrollment: 56 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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56 participants in 2 patient groups, including a placebo group

Single rising doses of BI 60732

Experimental group

Treatment:

Drug: BI 60732

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo