Bioavailability of BI 1356 With and Without Co-administration of Pioglitazone and the Bioavailability of Pioglitazone With and Without Coadministration of BI 1356 in Healthy Male and Female Volunteers

NCT02183337 | Completed Phase 1

• 1 other identifier: 1218.13
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate the bioavailability of BI 1356 with and without co-administration of pioglitazone and the bioavailability of pioglitazone with and without coadministration of BI 1356

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

  up to 21 days

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

  up to 21 days

Secondary Outcomes (13)

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

  up to 21 days

• C24,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 21 days

• λz,ss (terminal rate constant in plasma at steady state)

  up to 21 days

• t1/2,ss (terminal half-life of the analyte in plasma at steady state)

  up to 21 days

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

  up to 21 days

Study Arms (2)

BI 1356

EXPERIMENTAL

Treatment sequence AB\_C or C\_AB * Treatment A: 5 days BI 1356 until steady state followed by * Treatment B: combined treatment of BI 1356 with pioglitazone for 7 days * Treatment C: 7 days of treatment with Pioglitazone alone

Drug: BI 1356; Drug: BI 1356 + Pioglitazone; Drug: Pioglitazone

Pioglitazone

ACTIVE COMPARATOR

Treatment sequence AB\_C or C\_AB * Treatment A: 5 days BI 1356 until steady state followed by * Treatment B: combined treatment of BI 1356 with pioglitazone for 7 days * Treatment C: 7 days of treatment with Pioglitazone alone

Drug: BI 1356; Drug: BI 1356 + Pioglitazone; Drug: Pioglitazone

Interventions

BI 1356 DRUG

BI 1356; Pioglitazone

BI 1356 + Pioglitazone DRUG

BI 1356; Pioglitazone

Pioglitazone DRUG

BI 1356; Pioglitazone

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 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 ≤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, 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; Pioglitazone

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines; Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring

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: February 1, 2007
• Primary Completion: April 1, 2007
• Last Updated: July 8, 2014

Record last verified: 2014-07