Relative Bioavailability of BI 10773 and Linagliptin in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 10773; Drug: Linagliptin

• Registration Number: NCT02172222
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Study to investigate the relative bioavailability of BI 10773 and of linagliptin after concomitant multiple oral administration of 50 mg BI 10773 tablets and 5 mg linagliptin in comparison to 50 mg BI 10773 and 5 mg linagliptin given alone.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2009-09
• Status Verified: 2014-06
• Study First Submitted: 2014-06-20
• Study First Submitted QC: 2014-06-20
• Last Update Submitted: 2014-06-20
• Study First Posted: 2014-06-24
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

• Healthy male volunteers according to the following criteria:

  • Based upon a complete medical history and physical examination including vital signs (BP (blood pressure), PR (pulse rate)), 12-lead ECG (electrocardiogram) and clinical laboratory tests

• Age 18 to 50 years (inclusive)

• BMI 18.5 to 29.9 kg/m2 (inclusive)

• Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation.

Read More

Exclusion Criteria

• 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/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
• 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 30 g/day)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
• Excessive physical activities (within one week prior to administration or during the trial)
• Any laboratory value outside the reference range that is of clinical relevance
• Inability to comply with dietary regimen of trial site

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence ABC	BI 10773	1. Treatment A: BI 10773 once daily from day 1 to 5 2. Treatment B: BI10773 and linagliptin once daily from day 1 to 7 3. Treatment C: Linagliptin once daily from day 1 to 7
Sequence ABC	Linagliptin	1. Treatment A: BI 10773 once daily from day 1 to 5 2. Treatment B: BI10773 and linagliptin once daily from day 1 to 7 3. Treatment C: Linagliptin once daily from day 1 to 7
Sequence CAB	BI 10773	1. Treatment C: Linagliptin once daily from day 1 to 7 2. Treatment A: BI 10773 once daily from day 1 to 5 3. Treatment B: BI10773 and linagliptin once daily from day 1 to 7
Sequence CAB	Linagliptin	1. Treatment C: Linagliptin once daily from day 1 to 7 2. Treatment A: BI 10773 once daily from day 1 to 5 3. Treatment B: BI10773 and linagliptin once daily from day 1 to 7

Primary Outcome Measures

Name	Time	Method
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)	up to day 8
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)	up to day 8

Secondary Outcome Measures

Name	Time	Method
tmax,ss (time from last dosing to the maximum measured concentration of each analyte in plasma at steady state)	up to day 8
Urine glucose excretion (UGE)	Pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 hours after the last dosing of each visit
Plasma DPP-4 (Dipeptidyl-peptidase 4) inhibition	2 hours and 24 hours after last administration of study drug
Changes from baseline in physical examination	Baseline and within 5 days after last study drug administration
Changes from baseline in vital signs (blood pressure, pulse rate)	Baseline, day 1 and within 5 days after last study drug administration
Changes from baseline in 12-lead ECG (electrocardiogram)	Baseline and within 5 days after last study drug administration
Changes from baseline clinical laboratory tests	Baseline, day 1 and within 5 days after last study drug administration
Incidence of adverse events	Up to 56 days
Assessment of tolerability by investigator on a 4-point scale	Within 5 days after last study drug administration