Pharmacokinetics and Pharmacodynamics of Multiple 5 mg Doses of BI 1356 p.o. Given Once Daily Compared to Multiple 2.5 mg Doses Given Twice Daily in Healthy Male and Female Volunteers

NCT02173652 | Completed Phase 1

• 1 other identifier: 1218.45
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective was to investigate the influence of 2 different dosage regimens (5 mg once daily vs. 2.5 mg twice daily) on the steady-state pharmacokinetics and pharmacodynamics of orally administered BI 1356.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• AUC0-24,ss (area under the concentration-time curve of the analyte in plasma over the time interval 0 to 24 hours at steady state)

  up to 336 h after first administration of study drug

Secondary Outcomes (16)

• Cmax,ss (concentration of the analyte in plasma at steady state after administration of the last dose at the end of the dosing interval)

  up to 336 h after first administration of study drug

• Cpre,N (predose concentration of the analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered)

  up to 336 h after first administration of study drug

• tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)

  up to 336 h after first administration of study drug

• AUCss (area under the concentration-time curve of the analyte in plasma at steady state) for several time points

  up to 336 h after first administration of study drug

• MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)

  up to 336 h after first administration of study drug

Study Arms (2)

BI 1356, high dose

EXPERIMENTAL

Treatment A: 7 days of BI 1356 treatment given once daily

Drug: BI 1356, high dose

BI 1356, low dose

ACTIVE COMPARATOR

Treatment B: 7 days of BI 1356 treatment given twice daily

Drug: BI 1356, low dose

Interventions

BI 1356, high dose DRUG

BI 1356, high dose

BI 1356, low dose DRUG

BI 1356, low dose

Eligibility Criteria

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

You may qualify if:

• Healthy females and males based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
• Age ≥18 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 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
• Surgery of the gastrointestinal tract (except appendectomy)
• 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 (e.g. HIV)
• 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 or that prolong the QT/QTc interval 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

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: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 25, 2014
• Study Start: March 1, 2008
• Primary Completion: April 1, 2008
• Last Updated: July 8, 2014

Record last verified: 2014-07