Bioavailability of BI 10773 and Sitagliptin in Healthy Male Volunteers

NCT02172196 | Completed Phase 1

• 1 other identifier: 1245.27
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective was to investigate whether there was a drug-drug interaction between BI 10773 and sitagliptin when co-administered as multiple oral doses. Therefore, the relative bioavailabilities of BI 10773 and sitagliptin were determined when both drugs were given in combination compared with BI 10773 or sitagliptin given alone.

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)

  Days 1-8

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

  Days 1-8

Secondary Outcomes (17)

• C24,N (concentration of analyte in plasma at 24 hours post-drug administration after administration of the Nth dose)

  Days 1-8

• λz,ss (terminal half-life of the analyte in plasma)

  Days 1-8

• t½,ss (terminal half-life of the analyte in plasma at steady state)

  Days 1-8

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

  Days 1-8

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

  Days 1-8

Study Arms (2)

Treatment sequence ABC

EXPERIMENTAL

1. Treatment A: BI 10773 once daily from day 1 to 5 2. Treatment B: BI 10773 and sitagliptin once daily from day 1 to 5 3. Treatment C: Sitagliptin once daily from day 1 to 5

Drug: BI 10773; Drug: Sitagliptin

Treatment sequence CAB

EXPERIMENTAL

1. Treatment C: Sitagliptin once daily from day 1 to 5 2. Treatment A: BI 10773 once daily from day 1 to 5 3. Treatment B: BI 10773 and sitagliptin once daily from day 1 to 5

Drug: BI 10773; Drug: Sitagliptin

Interventions

BI 10773 DRUG

Treatment sequence ABC; Treatment sequence CAB

Sitagliptin DRUG

Treatment sequence ABC; Treatment sequence CAB

Eligibility Criteria

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

You may qualify if:

• Healthy male volunteers according to the following criteria:
• Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
• Age 18 to 50 years (incl.)
• BMI 18.5 to 29.9 kg/m2 (incl.)
• Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) 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 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
• 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 30 g/day)
• 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

empagliflozin; Sitagliptin Phosphate

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

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 20, 2014
• First Posted: June 24, 2014
• Study Start: May 1, 2009
• Primary Completion: July 1, 2009
• Last Updated: June 24, 2014

Record last verified: 2014-06