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LY3202626

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Apr 19, 2021

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 Trials2
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03023826A Study of LY3202626 in Healthy ParticipantsPHASE1 COMPLETED 26Jan 15, 2017Apr 4, 2017Apr 19, 20211 Singapore
NCT02555449A Study of [¹⁴C]-LY3202626 in Healthy Male ParticipantsPHASE1 COMPLETED 6Sep 1, 2015Nov 1, 2015Apr 19, 20211 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3202626
Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose

Pharmacokinetics (PK) is the maximum observed drug concentration (Cmax) of LY3202626

PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3202626
Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose

PK is the area under the concentration versus time curve from time zero to infinity (AUC\[0-∞\]) of LY3202626

PK: AUC From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3202626
Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose

PK is the AUC from time zero to time t, where t is the last time point with a measurable concentration (AUC\[0-tlast\]) of LY3202626

Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met

Fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered.

Urinary Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met

Urinary excretion of radioactivity over time was expressed as a percentage of the total radioactive dose administered

Secondary Endpoints
Plasma Radioactivity Pharmacokinetics Maximum Observed Concentration (Cmax)
Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
Plasma Radioactivity Pharmacokinetics Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-∞])
Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
Plasma Radioactivity Pharmacokinetics Area Under the Concentration-time Curve From Time Zero to the Last Timepoint With a Measurable Concentration (AUC[0-tlast])
Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY3202626 (R-Fasting)EXPERIMENTALSingle oral dose of LY3202626 (R) capsule under fasting conditions.
LY3202626 (T1-Fasting)EXPERIMENTALSingle oral dose of LY3202626 (T1) tablet under fasting conditions.
LY3202626 (T1-Fed)EXPERIMENTALSingle oral dose of LY3202626 (T1) following a high fat breakfast.
[¹⁴C]-LY3202626EXPERIMENTALSingle oral dose of LY3202626 containing 100 micro curies of radioactivity
Interventions
NameTypeDescription
LY3202626 (R-Fasting)DRUGAdministered orally
LY3202626 (T1-Fasting)DRUGAdministered orally
LY3202626 (T1-Fed)DRUGAdministered orally
[¹⁴C]-LY3202626DRUGAdministered as solution by mouth
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Eligibility Criteria
Age Range21 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Are overtly healthy males or females, as determined by medical history and physical examination * Female participants must be of non-childbearing potential confirmed by medical history or menopause * Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/...

Countries:SingaporeUnited States
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