Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 1356 BS in Healthy Male Volunteers

NCT02183298 | Completed Phase 1

• 1 other identifier: 1218.10
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1356 as formulation for intravenous administration

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Number of patients with abnormal findings in physical examination

  Screening, up to 14 days following drug administration

• Number of patients with clinically changes in vital signs (blood pressure [BP], pulse rate [PR])

  Screening, up to 14 days following drug administration

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

  Screening, up to 14 days following drug administration

• Number of patients with abnormal changes in laboratory parameters

  Screening, up to 14 days following drug administration

• Number of patients with adverse events

  up to 35 days

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

  up to 14 days following drug administration

Secondary Outcomes (15)

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

  predose, up to 192 h following drug administration

• tmax (time from dosing to maximum measured concentration)

  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

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

  predose, up to 192 h following 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)

  predose, up to 192 h following drug administration

Study Arms (2)

BI 1356 BS - single rising dose

EXPERIMENTAL

Drug: BI 1356 BS - intravenous; Drug: BI 1356 BS - Tablet

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 1356 BS - intravenous DRUG

BI 1356 BS - single rising dose

BI 1356 BS - Tablet DRUG

BI 1356 BS - single rising dose

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 50 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 (Blood pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests
• Age ≥18 and Age ≤50 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

You may not qualify if:

• Any finding of the medical examination (including BP, PR 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 drug or its excipients)
• 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
• Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 60 g/day)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Linagliptin

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 8, 2014
• Study Start: May 1, 2006
• Primary Completion: July 1, 2006
• Last Updated: July 8, 2014

Record last verified: 2014-07