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LY3045697

Phase 1

Undisclosed | Small molecule | Other |Eli Lilly and Company|Trials Updated: Oct 10, 2013

LY3045697 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Dec 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment51

FDA Designations

No designations recorded

LY3045697 clinical trials

LY3045697 · 2 trials · 1 indication

Phase 1 2
NCT01821703A Study of LY3045697 After Multiple Oral Dosing in Healthy ParticipantsHealthy Volunteers
COMPLETED24 Analytics
NCT01750853A Study of LY3045697 in Healthy ParticipantsHealthy Volunteers
COMPLETED27 Analytics
PHASE1COMPLETED
A Study of LY3045697 After Multiple Oral Dosing in Healthy Participants
Healthy VolunteersUnlock trial analytics
PHASE1COMPLETED
A Study of LY3045697 in Healthy Participants
Healthy VolunteersUnlock trial analytics

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 to 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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Frequently asked questions about LY3045697

What is LY3045697?

LY3045697 is an investigational small molecule developed by Eli Lilly and Company. It has been studied in Phase 1 clinical trials in healthy adult volunteers, and no therapeutic indication has been disclosed. Both completed trials took place in the Netherlands and evaluated the drug in participants aged 18 years and older.

Who makes LY3045697?

LY3045697 is made and developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored both Phase 1 trials of the compound, which were conducted in the Netherlands in healthy volunteers.

What phase is LY3045697 in?

LY3045697 is in Phase 1 development. Two Phase 1 trials have been completed, and no later-stage trials are listed. The studies enrolled a combined 51 healthy participants, and the compound remains investigational rather than approved for any use.

What clinical trials is LY3045697 in?

Two completed Phase 1 trials have studied LY3045697. NCT01821703 evaluated multiple oral doses in 24 healthy participants, and NCT01750853 studied the drug in 27 healthy participants. Both were conducted in the Netherlands, were randomized, double-blind, and placebo-controlled, and enrolled adults aged 18 years and older.

How was LY3045697 studied in its clinical trials?

Both LY3045697 trials were Phase 1 studies in healthy volunteers conducted in the Netherlands. NCT01821703 tested multiple oral doses in 24 participants, while NCT01750853 enrolled 27 participants. Each study used a randomized, double-blind, placebo-controlled design, and both have been completed.