NCT02171793
Completed
Phase 1
A Randomised, Single-blind, Placebo-controlled (Within Dose Groups) Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Peroral Doses (15, 30, 40 μg Free Cation) BI 1744 CL in Healthy Male Volunteers
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 24
- Primary Endpoint
- Number of patients with abnormal findings in physical examination
Overview
Brief Summary
Study to investigate safety, tolerability, and pharmacokinetics of single rising peroral doses of BI 1744 CL.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single
Eligibility Criteria
- Ages
- 21 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 ≤45 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
Exclusion Criteria
- •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
Arms & Interventions
BI 1744 CL
Experimental
Intervention: BI 1744 CL (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of patients with abnormal findings in physical examination
Time Frame: Baseline, day 17
Number of patients with clinically significant changes in vital signs (blood pressure (BP), pulse rate (PR), respiration rate (RR), oral body temperature)
Time Frame: Baseline, up to day 17
Number of patients with clinically relevant abnormal findings in 12-lead electrocardiogram (ECG)
Time Frame: Baseline, up to day 17
Number of patients with clinically significant changes in clinical laboratory tests
Time Frame: Baseline, up to day 17
Number of patients with Adverse events (AEs)
Time Frame: 5 weeks
Assessment of tolerability by investigator on a 4-point scale
Time Frame: Day 17
Secondary Outcomes
- Cmax (maximum measured concentration of the analyte in plasma)(pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration)
- tmax (time from dosing to maximum measured concentration of the analyte in plasma)(pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 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)(pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration)
- %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)(pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 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)(pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration)
- λz (terminal rate constant in plasma)(pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration)
- t1/2 (terminal half-life of the analyte in plasma)(pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration)
- MRTpo (mean residence time of the analyte in the body after peroral administration)(pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration)
- CL/F (apparent clearance of the analyte in plasma after peroral administration, will not be calculated for metabolites)(pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration)
- Vz/F (apparent volume of distribution during the terminal phase λz following a peroral dose, will not be calculated for metabolites)(pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration)
- Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)(pre-dose and 0-4, 4-8, 8-12, 12-24, 24-48 h after drug administration)
- fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)(pre-dose and 0-4, 4-8, 8-12, 12-24, 24-48 h after drug administration)
- CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)(pre-dose and 0-4, 4-8, 8-12, 12-24, 24-48 h after drug administration)
Investigators
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