Safety, Tolerability and Pharmacokinetics of BEA 2180 BR in Healthy Male Volunteers

NCT02254720 | Completed Phase 1

• 1 other identifier: 1205.5
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluation of safety, tolerability and pharmacokinetics of single rising intravenous doses of BEA 2180 BR; additional exploration of metabolism following inhalation

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Number of participants with abnormal findings in physical examination

  Up to day 12 after drug administration

• Number of participants with clinically significant changes in vital signs

  Up to day 12 after drug administration

• Number of participants with abnormal findings in 12 - lead ECG (electrocardiogram)

  Up to day 12 after drug administration

• Number of participants with abnormal changes in clinical laboratory parameters

  Up to day 12 after drug administration

• Number of participants with adverse events

  Up to day 12 after drug administration

• Investigator assessed tolerability on a 4-point scale

  Up to day 12 after drug administration

Secondary Outcomes (14)

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

  Up to 72 hours after drug administration

• tmax (time from dosing to maximum measured concentration)

  Up to 72 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 72 hours after drug administration

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

  Up to 72 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 72 hours after drug administration

Study Arms (3)

BEA 2180 BR IV

EXPERIMENTAL

Rising doses

Drug: BEA 2180 BR solution for infusion

Placebo

PLACEBO COMPARATOR

Drug: Placebo

BEA 2180 BR inhalation

EXPERIMENTAL

Drug: BEA 2180 BR solution for inhalation; Device: Respimat®

Interventions

BEA 2180 BR solution for infusion DRUG

BEA 2180 BR IV

Placebo DRUG

Intravenous infusion

Placebo

BEA 2180 BR solution for inhalation DRUG

BEA 2180 BR inhalation

Respimat® DEVICE

BEA 2180 BR inhalation

Eligibility Criteria

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

You may qualify if:

• Healthy male based upon a complete medical history, including the physical examination, regarding vital signs (BP, PR), 12 lead ECG measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease.
• Age ≥21 and ≤50 years
• BMI ≥18.5 and \<29.9 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 blood pressure (BP), pulse rate (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 2 months 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 for men)
• Drug abuse
• Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Inhalation

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

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: October 1, 2014
• First Posted: October 2, 2014
• Study Start: September 1, 2006
• Primary Completion: December 1, 2006
• Last Updated: October 2, 2014

Record last verified: 2014-09