Safety, Tolerability and Pharmacokinetics Study of BI 1744 CL in Healthy Male Subjects

Healthy Clinical Trial

Official title:

Safety, Tolerability and Pharmacokinetics of Single Rising Doses of 0.5 μg, 2.5 μg, 5 μg, 10 μg, 15 μg, 20 μg, 25 μg and 30 μg BI 1744 CL (Calculated as Free Base) Given as Intravenous Infusion Over 30 Minutes to Healthy Male Subjects. A Single-centre, Single-blind, Placebo-controlled, Randomised Study.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02172131
• Other study ID #: 1222.7
• Status: Terminated
• Phase: Phase 1
• First received: June 20, 2014
• Last updated: June 20, 2014
• Start date: October 2006

Study information

• Verified date: May 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

To investigate safety, tolerability, and pharmacokinetics (PK) of single i.v. doses of BI 1744 CL

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. primary completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy male based upon a complete medical history, including the physical examination, regarding vital signs (blood pressure (BP), pulse rate (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 =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 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 medication

• 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 medication

• Participation in another trial with an investigational drug within 2 months prior to medication

• 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 (more than 40 g alcohol a day)

• Drug abuse

• Blood donation (more than 100 mL blood within 4 weeks prior to medication or during the trial)

• Excessive physical activities within 1 week prior to randomisation or during the trial

• Any laboratory value outside the reference range that is of clinical relevance

• Inability to comply with dietary regimen of the study centre.

The following exclusion criteria are specific for this study due to the known class side effect profile of ß2-mimetics:

• Asthma or history of pulmonary hyperreactivity

• Hyperthyrosis

• Allergic rhinitis in need of treatment

• Clinically relevant cardiac arrhythmia

• Paroxysmal tachycardia (>100 beats per minute)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BI 1744 CL

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with abnormal findings in physical examination		Baseline, Day 10 after drug administration	No
Primary	Number of patients with clinically significant changes in vital signs		Baseline and up to day 10 after drug administration	No
Primary	Number of patients with abnormal changes in 12-lead ECG (electrocardiogram) parameters		Baseline and up to day 10 after drug administration	No
Primary	Number of patients with abnormal changes in laboratory parameters		Baseline and up to day 10 after administration	No
Primary	Number of patients with adverse events		Up to day 10	No
Primary	Assessment of tolerability by investigator on a 4-point scale		Day 10 after drug administration	No
Secondary	AUC (area under the concentration-time curve of the analyte in plasma at different time points)		Up to 48 hours after drug administration	No
Secondary	Cmax (maximum measured concentration of the analyte in plasma)		Up to 48 hours after drug administration	No
Secondary	tmax (time from dosing to maximum measured concentration)		Up to 48 hours after drug administration	No
Secondary	%AUCtz-8 (the percentage of the AUC0-8 that is obtained by extrapolation)		Up to 48 hours after drug administration	No
Secondary	?z (terminal rate constant in plasma)		Up to 48 hours after drug administration	No
Secondary	t1/2 (terminal half-life of the analyte in plasma)		Up to 48 hours after drug administration	No
Secondary	MRT (mean residence time of the analyte in the body after intravenous administration)		Up to 48 hours after drug administration	No
Secondary	CL (total clearance of the analyte in plasma after intravascular administration)		Up to 48 hours after drug administration	No
Secondary	V (apparent volume of distribution at different time points following an intravascular dose)		Up to 48 hours after drug administration	No
Secondary	Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)		Up to 96 hours after drug administration	No
Secondary	fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)		Up to 96 hours after drug administration	No
Secondary	CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)		Up to 96 hours after drug administration	No

External Links

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