Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BEA 2180 BR in Healthy Male Volunteers

NCT02254135 | Completed Phase 1

• 1 other identifier: 1205.20
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate safety, tolerability, and pharmacokinetics of single rising peroral doses of BEA 2180 BR

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Number of subjects with abnormal findings in physical examination

  up to 14 days after last procedure

• Number of subjects with clinically significant changes in vital signs

  (Blood pressure (BP), pulse rate (PR), respiration rate (RR), oral body temperature)

  up to 14 days after last procedure

• Number of subjects with clinically significant changes in 12-lead electrocardiogram (ECG)

  up to 14 days after last procedure

• Number of subjects with abnormal changes in laboratory parameters

  up to 14 days after last procedure

• Number of subjects with adverse events

  up to 14 days after last procedure

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

  14 days after last procedure

Secondary Outcomes (13)

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

  up to 48 h after drug administration

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

  up to 48 h 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 48 h after drug administration

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

  up to 48 h 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 h after drug administration

Study Arms (2)

BEA 2180 BR solution - rising dose

EXPERIMENTAL

Drug: BEA 2180 BR - rising dose

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BEA 2180 BR - rising dose DRUG

BEA 2180 BR solution - rising dose

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 55 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 ≥21 and ≤55 years
• BMI ≥18.5 and \<30 kg/m2 (Body Mass Index)
• 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 BP, PR, and ECG measurements) deviating from normal and of clinical relevance
• 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 the drug or its excipients) as judged clinically relevant by the investigator
• Intake of drugs with a long half-life (\>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomisation
• Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to enrolment in the study or during the study
• Participation in another trial with an investigational drug within 30 days prior to randomisation
• Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
• Inability to refrain from smoking on trial days as judged by the investigator
• Alcohol abuse (regularly more than 40 g alcohol per day)
• Drug abuse
• Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)

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: September 30, 2014
• First Posted: October 1, 2014
• Study Start: December 1, 2006
• Primary Completion: January 1, 2007
• Last Updated: October 1, 2014

Record last verified: 2014-09