Bioavailability of BI 1356 and Glyburide in Healthy Male and Female Volunteers

NCT02183428 | Completed Phase 1

• 1 other identifier: 1218.30
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study was to investigate the effect of multiple doses BI 1356 given once daily in the estimated highest therapeutic dose of 5 mg until steady state on the pharmacokinetics, safety, and tolerability of a single oral conventional therapeutic dose of 1.75 mg glyburide. In addition, the effect of glyburide as a single oral dose of 1.75 mg being a conventional therapeutic dose on the multiple dose pharmacokinetics of BI 1356 was investigated. Pharmacokinetic profiles of glyburide were determined when given alone or in combination with BI 1356. Pharmacokinetic profiles of BI 1356 and its inactive metabolite CD 1750 were determined at steady state of BI 1356 when given alone or in combination with glyburide.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• AUC0-infinity (area under the concentration-time curve of glyburide in plasma) for several time points

  up to 48 hours after drug administration

• Cmax (maximum measured concentration of glyburide in plasma) for several time points

  up to 48 hours after drug administration

• AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) of BI 1356

  up to 48 h after drug administration

• Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of BI 1356

  up to 48 h after drug administration

Secondary Outcomes (10)

• tmax (time from dosing to the maximum concentration of the analyte in plasma) for several time points

  up to 48 hours after drug administration

• λz (terminal rate constant in plasma)

  up to 48 hours after drug administration

• t1/2 (terminal half-life of the analyte in plasma)

  up to 48 hours after drug administration

• MRTpo (mean residence time of the analyte in the body after po administration) for several time points

  up to 48 hours after drug administration

• CL/F (apparent clearance of the analyte in the plasma after extravascular administration) for several time points

  up to 48 hours after drug administration

Study Arms (2)

BI 1356

EXPERIMENTAL

Treatment sequence AB\_C or C\_AB * Treatment A: 5 days of treatment with BI 1356 once per day until steady state followed by * Treatment B: 1 day of combined treatment of BI1356 and glyburide * Treatment C: 1 day of treatment with glyburide alone

Drug: BI 1356; Drug: Glyburide; Drug: BI 1356 + Glyburide

Glyburide

ACTIVE COMPARATOR

Treatment sequence AB\_C or C\_AB * Treatment A: 5 days of treatment with BI 1356 once per day until steady state followed by * Treatment B: 1 day of combined treatment of BI1356 and glyburide * Treatment C: 1 day of treatment with glyburide alone

Drug: BI 1356; Drug: Glyburide; Drug: BI 1356 + Glyburide

Interventions

BI 1356 DRUG

BI 1356; Glyburide

Glyburide DRUG

BI 1356; Glyburide

BI 1356 + Glyburide DRUG

BI 1356; Glyburide

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy females and 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 (ECG) Electrocardiogram, clinical laboratory tests
• Age ≥18 and Age ≤55 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
• History of relevant allergy or 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, including herbal products
• 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; Glyburide

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines; Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

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: May 1, 2008
• Primary Completion: July 1, 2008
• Last Updated: July 8, 2014

Record last verified: 2014-07