Bioavailability of BI 1356 Administered With and Without Food to Healthy Male and Female Subjects

NCT02183493 | Completed Phase 1

• 1 other identifier: 1218.34
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate the food effect on the relative bioavailability and pharmacokinetics of a 5 mg BI 1356 tablet administered as a single dose

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve of BI 1356 in plasma over the time interval from 0 to 72 h (AUC0-72)

  up to 72 hours after start of treatment

• Maximum measured concentration (Cmax) of BI 1356 in plasma

  up to 96 hours after start of treatment

Secondary Outcomes (9)

• Area under the concentration-time curve of BI 1356 in plasma at different time points

  up to 96 hours after start of treatment

• Time from dosing to the maximum concentration (tmax) of BI 1356 in plasma

  up to 96 hours after start of treatment

• Terminal elimination rate constant (λz) in plasma

  up to 96 hours after start of treatment

• Terminal half-life (t1/2) of BI 1356 in plasma

  up to 96 hours after start of treatment

• Mean residence time of BI 1356 in the body after oral administration (MRTpo)

  up to 96 hours after start of treatment

Study Arms (2)

Fed administration of BI 1356

EXPERIMENTAL

Drug: BI 1356

Fasted administration of BI 1356

ACTIVE COMPARATOR

Drug: BI 1356

Interventions

BI 1356 DRUG

Fasted administration of BI 1356; Fed administration of BI 1356

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females 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 deviating from normal and of clinical relevance. Repeated measurement of a systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
• 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
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• Intake of drugs within one month or less than 10 half-lives of the respective drug prior to first study drug administration and during the trial except if a relevant interaction can be ruled out
• Participation in another trial with an investigational drug within two months prior to first study drug 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 (average consumption of more than 20 g/day in females and 30 g/day in males)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to the start of study)

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: July 4, 2014
• First Posted: July 8, 2014
• Study Start: October 1, 2008
• Primary Completion: December 1, 2008
• Last Updated: July 8, 2014

Record last verified: 2014-07