Phase 1 N=16 Randomized Treatment

DDI Between BI Empagliflozin (10773) and Verapamil

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT01276301 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2014

Primary outcome: Primary: Area Under the Curve 0 to Infinity (AUC0-∞) — 5190; 5340 nmol*h/L

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Verapamil (Drug); BI 10773 (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Feb 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Curve 0 to Infinity (AUC0-∞)	5190; 5340	—
PRIMARY Maximum Measured Concentration (Cmax)	785; 725	—
SECONDARY Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)	5140; 5280	—
SECONDARY Time From 0 to Maximum Plasma Concentration (Tmax)	1.50; 1.75	—
SECONDARY Terminal Elimination Rate Constant (λz)	0.0573; 0.0531	—
SECONDARY Terminal Half-life in Plasma (t1/2)	12.1; 13.1	—
SECONDARY Mean Residence Time in the Body After Administration (MRTpo)	9.47; 9.95	—
SECONDARY Apparent Clearance in Plasma After Extravascular Administration (CL/F)	178; 173	—
SECONDARY Apparent Volume of Distribution Following an Extravascular Dose (Vz/F)	186; 195	—
SECONDARY Clinically Relevant Abnormalities for Physical Examination, Vital Signs, Blood Chemistry and Electrocardiogram (ECG).	0; 0	—
SECONDARY Assessment of Tolerability by Investigator	100.0; 87.5; 0.0; 6.3; 0.0; 6.3	—

Summary

Relative bioavailability of BI 10773 given alone and together with verapamil

Eligibility Criteria

Inclusion criteria

healthy male and female subjects

Exclusion criteria

Any relevant deviation from healthy conditions

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Data sourced from ClinicalTrials.gov (NCT01276301). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.