Safety and Pharmacokinetics of Single Rising Oral Doses of BI 224436 ZW in Healthy Male Volunteers.

NCT02183662 | Completed Phase 1

• 1 other identifier: 1277.1
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate safety and pharmacokinetics of BI 224436 ZW

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• maximum measured concentration of the analyte in plasma

  up to 72 hours

• area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 24

  up to 24 hours

Secondary Outcomes (18)

• area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity

  up to 72 hours

• minimum observed concentration at 24 hours

  up to 24 hours

• terminal half-life of the analyte in plasma

  up to 72 hours

• time from dosing to maximum measured concentration of the analyte in plasma

  up to 72 hours

• apparent clearance of the analyte in plasma

  up to 72 hours

Study Arms (2)

BI 224436

EXPERIMENTAL

Drug: BI 224436

Placebo

PLACEBO COMPARATOR

Drug: Placebo to BI 224436

Interventions

BI 224436 DRUG

BI 224436

Placebo to BI 224436 DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males
• Age ≥21 and Age ≤50 years
• Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and the local legislation.

You may not qualify if:

• Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and electrocardiogram (ECG)) deviating from normal and of clinical relevance
• 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
• HIV infection and other chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
• Use of drugs which might reasonably 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 one month prior to administration or during the trial
• Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 60 g/day)
• Drug abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

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

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 8, 2014
• Study Start: November 1, 2009
• Primary Completion: March 1, 2010
• Last Updated: July 8, 2014

Record last verified: 2014-07