Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1356 BS Administered to Healthy Male Subjects

NCT02173665 | Completed Phase 1

• 1 other identifier: 1218.1
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Number of patients with adverse events

  up to 30 days

• Number of patients with abnormal findings in physical examination

  Screening, up to 16 days after drug administration

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

  Screening, up to 16 days after drug administration

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

  Screening, up to 16 days after drug administration

• Number of patients with abnormal changes in laboratory parameters

  Screening, up to 16 days after drug administration

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

  up to 16 days after drug administration

Secondary Outcomes (14)

• Cmax (maximum concentration 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

• 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 (3)

BI 1356 BS - Powder in bottle (PIB)

EXPERIMENTAL

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

BI 1356 BS - Tablet

EXPERIMENTAL

Drug: BI 1356 BS - Tablet

Placebo

ACTIVE COMPARATOR

Drug: Placebo

Interventions

BI 1356 BS - Powder in bottle (PIB) DRUG

BI 1356 BS - Powder in bottle (PIB)

BI 1356 BS - Tablet DRUG

BI 1356 BS - Tablet

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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), 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

You may not qualify if:

• 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
• 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: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 25, 2014
• Study Start: October 1, 2004
• Primary Completion: December 1, 2004
• Last Updated: July 8, 2014

Record last verified: 2014-07