Safety, Tolerance, and Pharmacokinetics of BILN 2061 ZW in Healthy Male Subjects, Combined With Preliminary Evaluation of Food Effect

NCT02268760 | Completed Phase 1

• 1 other identifier: 605.1
• Study Type: interventional
• Target: 103
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the safety, tolerance and pharmacokinetics of 5 mg to 2400 mg BILN 2061 ZW

1. 1.In rising single doses
2. 2.With and without a 64 g fat breakfast at one selected dose

Conditions

Healthy

Outcome Measures

Primary Outcomes (14)

• Number of patients with clinically relevant changes in vital signs (systolic and diastolic blood pressure, pulse rate)

  Pre-dose, up to 48 hours after drug administration

• Changes from baseline in laboratory tests

  Pre-dose and 48 hours after drug administration

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

  Pre-dose, up to 48 hours after drug administration

• Changes from baseline in physical examination

  Pre-dose and 48 hours after drug administration

• Number of patients with adverse events

  Up to 48 hours after drug administration

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

  Up to 48 hours after drug administration

• Maximum concentration of the analyte in plasma after a single dose administration (Cmax)

  up to 48 hours after drug administration

• Area under the concentration-time curve of the analyte in plasma from time 0 to infinity (AUC0-infinity)

  up to 48 hours after drug administration

• Time to reach Cmax following a single dose administration (tmax)

  up to 48 hours after drug administration

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

  up to 48 hours after drug administration

• Total oral clearance of the analyte from plasma after oral administration, divided by F (bioavailability factor) (CL/F)

  up to 48 hours after drug administration

• Total mean residence time of the analyte in plasma (MRT)

  up to 48 hours after drug administration

• Apparent volume of distribution during the terminal elimination phase (Vz/F)

  up to 48 hours after drug administration

• Amount of intact drug excreted in urine (Au)

  up to 48 hours after drug administration

Study Arms (4)

BILN 2061 ZW single rising doses

EXPERIMENTAL

Drug: BILN 2061 ZW single rising doses

Placebo

PLACEBO COMPARATOR

Drug: Placebo

BILN 2061 ZW fixed dose fed

EXPERIMENTAL

Drug: BILN 2061 ZW fixed dose; Other: Standardized breakfast

BILN 2061 ZW fixed dose fasted

ACTIVE COMPARATOR

Drug: BILN 2061 ZW fixed dose

Interventions

BILN 2061 ZW single rising doses DRUG

BILN 2061 ZW single rising doses

Placebo DRUG

Placebo

BILN 2061 ZW fixed dose DRUG

BILN 2061 ZW fixed dose fasted; BILN 2061 ZW fixed dose fed

Standardized breakfast OTHER

BILN 2061 ZW fixed dose fed

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects as determined by results of screening
• Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
• Age ≥ 18 and ≤ 50 years
• Broca ≥ - 20 % and ≤ + 20 %

You may not qualify if:

• Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders, including a history of viral hepatitis, or serological evidence of active Hepatitis B or Hepatitis C infection
• History of orthostatic hypotension, fainting spells and blackouts
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
• Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within 1 month prior to administration or during the trial
• Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on trial days
• Alcohol abuse (\> 60 g/day)
• Drug abuse
• Blood donation within 1 month prior to administration or during the trial
• Excessive physical activities within 5 days prior to administration or during the trial
• Any laboratory value outside the clinically accepted reference range and of clinical relevance

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

BILN 2061

Study Design

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

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: October 20, 2014
• Study Start: June 1, 2001
• Primary Completion: September 1, 2001
• Last Updated: October 20, 2014

Record last verified: 2014-10