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

NCT02244203 | Completed Phase 1

• 1 other identifier: 1267.1
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Number of patients with clinically relevant changes in vital signs (blood pressure (BP), pulse rate (PR))

  up to day 21 after start of treatment

• Number of patients with clinically relevant changes in 12-lead ECG

  up to day 21 after start of treatment

• Number of patients with clinically relevant changes in laboratory parameters

  up to day 21 after start of treatment

• Number of patients with clinically relevant changes in coagulation parameters

  Parameters: * Activated partial thromboplastin time (aPTT) * Prothrombin time (PT) * HepTest®

  up to 72 hours after start of treatment

• Number of patients with adverse events

  up to 6 weeks

• Global assessment of tolerability by investigator on a 4-point scale

  up to 21 days after start of treatment

Secondary Outcomes (21)

• Maximum measured concentration of the analyte in plasma (Cmax)

  up to 264 hours after start of treatment

• Time from dosing to maximum measured concentration of the analyte in plasma (tmax)

  up to 264 hours after start of treatment

• Area under the concentration-time curve of the analyte in plasma (AUC)

  up to 264 hours after start of treatment

• Terminal rate constant of the analyte in plasma (λz)

  up to 264 hours after start of treatment

• Terminal half-life of the analyte in plasma (t1/2)

  up to 264 hours after start of treatment

Study Arms (2)

Single rising doses of BI 60732

EXPERIMENTAL

Drug: BI 60732

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 60732 DRUG

Single rising doses of BI 60732

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 19, 2014
• Study Start: February 1, 2009
• Primary Completion: July 1, 2009
• Last Updated: September 19, 2014

Record last verified: 2014-09