Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 44847 Administered to Healthy Male Subjects

NCT02211924 | Completed Phase 1

• 1 other identifier: 1224.11
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 44847 in Japanese healthy volunteers

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Number of patients with clinically relevant changes in vital signs

  up to day 7

• Number of patients with clinically relevant finding in 12-lead electrocardiogram (ECG)

  up to day 7

• Number of patients with clinically relevant changes in laboratory parameters

  up to day 7

• Number of patients with adverse events

  up to 5 weeks

Secondary Outcomes (17)

• Cmax (maximum concentration of the analyte in plasma)

  up to 48 hours after drug administration

• tmax (time from dosing to maximum concentration)

  up to 48 hours after drug administration

• AUC0-inf. (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  up to 48 hours after drug administration

• %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)

  up to 48 hours after drug administration

• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)

  up to 48 hours after drug administration

Study Arms (2)

BI 44847

EXPERIMENTAL

single rising dose

Drug: BI 44847

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 44847 DRUG

BI 44847

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects will be healthy male volunteers who meet the criteria below:
• Persons without clinically remarkable findings or clinically evident complications based on their concurrent illness, past medical history, physical examination, vital signs (blood pressure, pulse rate, and body temperature), 12-lead ECG, and laboratory test results
• Persons who are 20 or older and 35 or younger
• Persons with a BMI 18.5 kg/m2 or more and 25.0 kg/m2 less
• Persons who are willing to participate in this trial before study initiation and who give their written consent in accordance with Good Clinical Practice

You may not qualify if:

• Any finding of the medical examination (including BP, Pulse Rate (PR) and 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
• 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 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 any drugs within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within four months 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
• Blood donation (more than 100 mL) within four weeks prior to administration or during the trial

Sponsors & Collaborators

• Boehringer Ingelheim: lead

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: August 7, 2014
• First Posted: August 8, 2014
• Study Start: August 1, 2007
• Primary Completion: September 1, 2007
• Last Updated: August 8, 2014

Record last verified: 2014-08