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1 Empagliflozin/2 Metformin

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Mar 9, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02106923Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Extended Release (XR) Compared With Single TabletsPHASE1 COMPLETED 72 — — Apr 1, 2014Jul 1, 2014Mar 9, 20171 United States
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Study Endpoints
Primary Endpoints
AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point), for Empagliflozin
1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).

AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) for Metformin
1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point

Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Empagliflozin
1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

Maximum measured concentration of empagliflozin in plasma (Cmax).

Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Metformin
1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

Maximum measured concentration of metformin in plasma

Secondary Endpoints
AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Empagliflozin
1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Metformin
1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
High dose, fastedEXPERIMENTAL1 fixed dose combination (FDC) tablet vs 3 single tablets under fasted conditions
High dose, fedEXPERIMENTAL1 fixed dose combination (FDC) tablet vs 3 single tablets under fed conditions
Low dose, fastedEXPERIMENTAL2 fixed dose combination (FDC) tablets vs 4 single tablets under fasted conditions
Interventions
NameTypeDescription
1 tablet Empagliflozin/2 tablets Metformin XRDRUGActive Comparator: 1 x Empagliflozin/2x Metformin XR tablets
10 mg Empagliflozin/1000 mg Metformin XRDRUGExperimental: high dose Empagliflozin/Metformin XR, FDC tablet
1 tablet 10 mg Empagliflozin/3 tablets Metformin XRDRUGActive Comparator: 1 x Empagliflozin/3 x Metformin XR tablets
2 tablets 5 mg Empagliflozin/750 Metformin XRDRUGExperimental:2 x low dose Empagliflozin/Metformin XR FDC tablets
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria: 1. Healthy males or females 2. Age 18-50 years (incl.) 3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.) 4. Subjects must be able to understand and comply with study requirements Exclusion criteria: Any deviation from healthy condition

Countries:United States
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