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LY2835219

Phase 1

Healthy Volunteers | Small molecule | Other |Eli Lilly and Company|Last Updated: Jan 7, 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 Trials4
Total Enrollment65
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02327143A Study of LY2835219 in Healthy ParticipantsPHASE1 COMPLETED 11 — — Jan 1, 2015Feb 1, 2015Aug 6, 20181 United Kingdom
NCT02256267A Study of LY2835219 in Healthy ParticipantsPHASE1 COMPLETED 24 — — Oct 1, 2014Nov 1, 2014Jan 7, 20191 United States
NCT02059148A Study of LY2835219 in Healthy ParticipantsPHASE1 COMPLETED 24 — — Feb 1, 2014Aug 1, 2014Jan 7, 20191 United States
NCT01913314A Study of Carbon-14-Labeled LY2835219 ([^14C]-LY2835219) in Healthy ParticipantsPHASE1 COMPLETED 6 — — Aug 1, 2013Oct 1, 2013Jan 7, 20191 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Zero to Infinity [AUC(0-∞)] of LY2835219 and ¹³C₈-LY2835219
Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2835219
Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours
PK: Area Under the Concentration Time Curve AUC(0-∞) of LY2835219
Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours
Pharmacokinetics: Maximum Concentration (Cmax) of LY2835219 Fasted vs. High-Fat Arms
Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period
Pharmacokinetics: Area Under the Concentration Curve (0-t Last) [AUC(0-t Last)] of LY2835219 Fasted vs. High-Fat Arms
Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period
Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of LY2835219 Fasted vs. High-Fat Arms
Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period
Urinary and Fecal Excretion of LY2835219-Related Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Predose up to Day 14 postdose; Fecal samples collected at 24-hour (h) intervals; Urine collected at 0 to 6 h, 6 to 12 h, and 12 to 24 h postdose and at 24-h intervals thereafter up to Day 14 postdose

The percentage of the total radioactive dose administered that was excreted in urine or feces = (amount of radioactive dose recovered in urine or feces / total radioactive dose administered) \* 100.

Secondary Endpoints
PK: Maximum Observed Concentration (Cmax) of LY2835219
Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose
PK: Time of Maximum Observed Drug Concentration (Tmax) of LY2835219
Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose
Pharmacokinetics: Cmax of LY2835219 in Standard Meal Arm
Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
200 mg LY2835219EXPERIMENTAL200 mg LY2835219 administered orally on day 1.
0.4 mg ¹³C₈-LY2835219EXPERIMENTAL0.4 mg ¹³C₈-LY2835219 given intravenously (IV) for 15 minutes, starting approximately 6 hours after the oral dose.
LY2835219EXPERIMENTALSingle oral dose of LY2835219
LY2835219 + RifampinEXPERIMENTALSingle oral dose of LY2835219 with rifampin orally, once daily for 14 days
LY2835219 StandardEXPERIMENTALSingle oral dose of LY2835219 given with a standard meal in one of three study periods.
LY2835219 FastedEXPERIMENTALSingle oral dose of LY2835219 given with no food in one of three periods.
LY2835219 High-FatEXPERIMENTALSingle oral dose of LY2835219 given with a high fat meal in one of three periods.
[^14C]-LY2835219EXPERIMENTALSingle 150 milligram (mg) oral dose solution of LY2835219 containing 5 micro-curies of (µCi) \[\^14C\] labeled drug
Interventions
NameTypeDescription
LY2835219DRUGAdministered orally
¹³C₈-LY2835219DRUGAdministered IV
RifampinDRUGAdministered orally
[^14C]-LY2835219DRUGAdministered as oral solution
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Overtly healthy sterile males or surgically sterile females or postmenopausal females * Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m\^2) * Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site. *...

Countries:United KingdomUnited States
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