Safety, Tolerability and Pharmacokinetics of Single Rising Intravenous Doses of BI 44370 BS Solution in Healthy Male Volunteers

NCT02215031 | Completed Phase 1

• 1 other identifier: 1246.12
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate safety, tolerability, and pharmacokinetics of BI 44370 BS solution for intravenous (i.v.) infusion

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Number of patients with clinically significant findings in vital signs

  up to 16 days

• Number of patients with clinically significant findings in 12-lead electrocardiogram (ECG)

  up to 16 days

• Number of patients with clinically significant laboratory findings

  up to 16 days

• Number of patients with adverse events

  up to 37 days

• Assessment of global tolerability by investigator on a 4-point scale

  within 14 days after last trial procedure

Secondary Outcomes (16)

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

  up to 24 hours after drug administration

• tmax (time from dosing to maximum measured concentration)

  up to 24 hours after drug administration

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

  up to 24 hours after drug administration

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

  up to 24 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 24 hours after drug administration

Study Arms (2)

BI 44370

EXPERIMENTAL

Drug: BI 44370

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 44370 DRUG

BI 44370

Placebo 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 according to the following criteria based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR), Respiratory Rate (RR) and body temperature), 12-lead ECG, clinical laboratory tests
• Age 21 to 50 years inclusive
• Body Mass Index (BMI) 18.5 to 29.9 kg/m2 inclusive
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and German law

You may not qualify if:

• Any finding of the medical examination (including BP, PR, RR, body temperature 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
• 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 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 or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within two 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

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

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 13, 2014
• Study Start: September 1, 2008
• Primary Completion: November 1, 2008
• Last Updated: August 13, 2014

Record last verified: 2014-08