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LY2886721 in a

Phase 1

Healthy Volunteers | Small molecule | Other |Eli Lilly and Company|Last Updated: Jul 19, 2019

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 Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01775904A Study of Two Dosage Forms of LY2886721 in Healthy ParticipantsPHASE1 COMPLETED 26 — — Feb 1, 2013May 1, 2013Jul 19, 20191 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY2886721
Baseline through 96 hours post-dose
Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of LY2886721
Baseline through 96 hours post-dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC[0-tlast]) of LY2886721
Baseline through 96 hours post-dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞] of LY2886721
Baseline through 96 hours post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY2886721 Capsule (water, fasting)EXPERIMENTALReference formulation. A single oral dose of 70 milligrams (mg) LY2886721 in a capsule given with water and without a meal in one of four periods.
LY2886721 ODT (no water, fasting)EXPERIMENTALA single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given without water and without a meal in one of four periods.
LY2886721 ODT (water, fed)EXPERIMENTALA single oral dose of a 70 mg LY2886721 in an orally disintegrating tablet (ODT) given with water and after a high-fat breakfast in one of four periods.
LY2886721 ODT (water, fasting)EXPERIMENTALA single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given with water and without a meal in one of four periods.
Interventions
NameTypeDescription
LY2886721 in a CapsuleDRUGAdministered orally.
LY2886721 in an orally disintegrating tablet (ODT)DRUGAdministered orally.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Have a body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m\^2), inclusive, at screening * At least 4 participants who are greater than 55 years of age * Male participants: Agree to use a reliable method of birth control and not donate sperm during the study ...

Countries:United States
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