Clinical Trials/NCT02173665

NCT02173665

Completed

Phase 1

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1356 BS as a Solution at Dose Levels 2.5 -5 mg and Tablets at Dose Levels 25 - 600 mg Administered to Healthy Male Subjects. A Randomised, Double-blind, Placebo-controlled Trial, Including an Intra-subject Bioavailability Comparison of 100 mg BI 1356 BS as Tablet and as Solution. BI 1356 BS as Tablet and as Solution

Boehringer Ingelheim0 sites64 target enrollmentOctober 2004

ConditionsHealthy

InterventionsBI 1356 BS - Powder in bottle (PIB)BI 1356 BS - Tablet Placebo

DrugsBI 1356 BS - Powder in bottle (PIB)BI 1356 BS - Tablet Placebo

Overview

Phase: Phase 1
Intervention: BI 1356 BS - Powder in bottle (PIB)
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Enrollment: 64
Primary Endpoint: Number of patients with clinically significant changes in vital signs (blood pressure [BP], heart rate [HR])
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The objective of the current study was to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1356 BS.

Registry

clinicaltrials.gov

Start Date

October 2004

End Date

December 2004

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (Blood pressure (BP), Heart Rate (HR), 12-lead Electrocardiogram (ECG)), clinical laboratory tests
•Age ≥21 and Age ≤65 years
•BMI ≥18.5 and BMI ≤ 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

Exclusion Criteria

•Any finding of the medical examination (including BP, HR 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
•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 and lactose intolerance)
•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 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

Arms & Interventions

BI 1356 BS - Powder in bottle (PIB)

Intervention: BI 1356 BS - Powder in bottle (PIB)

BI 1356 BS - Tablet

Intervention: BI 1356 BS - Tablet

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Number of patients with clinically significant changes in vital signs (blood pressure [BP], heart rate [HR])

Time Frame: Screening, up to 16 days after drug administration

Number of patients with abnormal changes in laboratory parameters

Time Frame: Screening, up to 16 days after drug administration

Assessment of tolerability by investigator on a 4-point scale

Time Frame: up to 16 days after drug administration

Number of patients with adverse events

Time Frame: up to 30 days

Number of patients with abnormal findings in physical examination

Time Frame: Screening, up to 16 days after drug administration

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

Time Frame: Screening, up to 16 days after drug administration

Secondary Outcomes

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)(predose, up to 192 h following drug administration)
t1/2 (terminal half-life of the analyte in plasma)(predose, up to 192 h following drug administration)
tmax (time from dosing to maximum concentration)(predose, up to 192 h following drug administration)
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)(predose, up to 192 h following drug administration)
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)(predose, up to 192 h following drug administration)
Cmax (maximum concentration of the analyte in plasma)(predose, up to 192 h following drug administration)
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(predose, up to 192 h following drug administration)
MRTpo (mean residence time of the analyte in the body after po administration)(predose, up to 192 h following drug administration)
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)(up to 120 h following drug administration)
λz (terminal rate constant in plasma)(predose, up to 192 h following drug administration)
CL/F (total clearance of the analyte in the plasma after extravascular administration)(predose, up to 192 h following drug administration)
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)(up to 120 h following drug administration)
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)(up to 120 h following drug administration)
Changes of Dipeptidyl-Peptidase IV (DPP-IV) activity in plasma(predose, up to 96 h following drug administration)