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LY3045697

Phase 1

Healthy Volunteers | Small molecule | Other |Eli Lilly and Company|Last Updated: Oct 10, 2013

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment51
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01821703A Study of LY3045697 After Multiple Oral Dosing in Healthy ParticipantsPHASE1 COMPLETED 24 — — May 1, 2013Sep 1, 2013Oct 10, 20131 Netherlands
NCT01750853A Study of LY3045697 in Healthy ParticipantsPHASE1 COMPLETED 27 — — Jan 1, 2013Jul 1, 2013Jul 26, 20131 Netherlands
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Study Endpoints
Primary Endpoints
Number of Participants with One or More Clinically Significant Adverse Events (AEs) or Any Serious AEs
Baseline to 10 days post last dose (Estimated up to 8 weeks)
Secondary Endpoints
Pharmacokinetics: Maximum Serum Concentration (Cmax) of LY3045697
Predose to 24 hours after dosing on Day 8 of each dosing period
Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) from Zero to Infinity (AUC 0-∞) of LY3045697
Predose to 24 hours after dosing on Day 8 of each dosing period
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
LY3045697EXPERIMENTALEscalating dose (0.1 milligrams \[mg\] up to 100 mg) of LY3045697 administered once daily, orally, for 8 days in 2 of 3 dosing periods
SpironolactoneACTIVE_COMPARATOR25 mg spironolactone administered once daily, orally, for 8 days in up to 1 of 3 dosing periods
PlaceboPLACEBO_COMPARATORPlacebo matching LY3045697 administered once daily, orally for 8 days in up to 1 of 3 dosing periods
Group 1EXPERIMENTALPeriod 1: 0.1 milligrams (mg) LY3045697 administered once orally or matching placebo administered once orally. Period 2: 1 mg LY3045697 administered once orally or matching placebo administered once orally. Period 3: 10 mg LY3045697 administered once orally or matching placebo administered once orally.
Group 2EXPERIMENTALPeriod 1: 0.3 mg LY3045697 administered once orally or matching placebo administered once orally. Period 2: 3 mg LY3045697 administered once orally or matching placebo administered once orally. Period 3: 30 mg LY3045697 administered once orally or matching placebo administered once orally.
Group 3EXPERIMENTALPeriod 1: 100 mg of LY3045697 administered once orally or matching placebo administered once orally. Period 2: 300 mg of LY3045697 administered once orally or matching placebo administered once orally (via split delivery over a 15-minute period).
Interventions
NameTypeDescription
LY3045697DRUGAdministered as oral solution
PlaceboDRUGAdministered as oral solution
SpironolactoneDRUGAdministered as capsule
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy men and women of non-child bearing potential as determined by medical history and physical examination * Male participants must agree to use a medically accepted method of contraception with all sexual partners during the study and for 90 days after the end of the fina...

Countries:Netherlands
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