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LY2584702 Reference Formulation

Phase 1

Healthy Participants | Small molecule | Other |Eli Lilly and Company|Last Updated: Jan 22, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment29

FDA Designations

No designations recorded

Clinical trial landscape

LY2584702 Reference Formulation · 1 trial · 1 indication

Phase 1 1
NCT01372085Single Dose Study in Healthy Participants to Investigate the Safety and Absorption of LY2584702Healthy Participants
COMPLETED29 Analytics
PHASE1COMPLETED
Single Dose Study in Healthy Participants to Investigate the Safety and Absorption of LY2584702
Healthy ParticipantsUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)
Part A: Day 1 and Part B: Periods 1 to 4, Day 1 [Predose, 1 hour (h), 3 h, 4 h, 6 h, 10 h, 24 h, 48 h postdose]

The Cmax following a single oral dose of LY2584702 test formulation \[TF (tablet)\] or reference formulation \[RF (capsule)\] is reported.

Secondary Endpoints

Pharmacokinetics, Area Under the Concentration-Time Curve (AUC)
Part A: Day 1 and Part B: Periods 1 to 4, Day 1 [Predose, 1 hour (h), 3 h, 4 h, 6 h, 10 h, 24 h, 48 h postdose]
Part B: Baseline-Adjusted Change-From-Predose in the Concentration of Lipids (Total Cholesterol)
Part B: Baseline [Periods 1 and 4a (Day -1)], Periods 3, 4a (Day 1). Lipid concentration measurements were performed at time point 0 and 1 hour (h), 3 h, 4 h, 6 h, 10 h, and 24 h.
Part A: QT Interval Corrected by Fridericia's Formula (QTcF) Change From Baseline to Day 1
Part A: Baseline [Day 1 (Predose)] and Day 1 (3 h, 4 h, 6 h, and 24 h postdose)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: 25 mg RFEXPERIMENTALA single 25 mg dose of LY2584702 RF
Part A: PlaceboPLACEBO_COMPARATORPlacebo taken orally
Part B: Sequence 1EXPERIMENTALA single 10 mg dose of LY2584702 TF during the first intervention period, followed by placebo in the second intervention period, followed by a single dose of 50 mg TF in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods.
Part B: Sequence 2EXPERIMENTALPlacebo during the first intervention period, followed by a single dose of 50 mg RF in the second intervention period, followed by a single dose of 50 mg TF in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods.
Part B: Sequence 3EXPERIMENTALA single 10 mg dose of LY2584702 TF during the first intervention period, followed by a single dose of 50 mg RF in the second intervention period, followed by a single dose of 50 mg TF in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods.
Part B: Sequence 4EXPERIMENTALA single 10 mg dose of LY2584702 TF during the first intervention period, followed by a single dose of 50 mg RF in the second intervention period, followed by placebo in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods.

Interventions

NameTypeDescription
LY2584702 Reference FormulationDRUGAdministered orally
LY2584702 Test FormulationDRUGAdministered orally
PlaceboDRUGAdministered orally
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Eligibility Criteria

Age Range21 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Male participants: • Agree to use a reliable method of birth control during the study and for at least 1 month following the last dose of study drug Female participants: • Women not of childbearing potential due to surgical sterilization (hysterectomy or bilateral oophorectom...

Countries:Singapore
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Frequently asked questions about LY2584702 Reference Formulation

What is LY2584702 used for?

LY2584702 is an investigational small molecule being studied for the treatment of cancer and for use in healthy participants. It was evaluated in Phase 1 clinical trials, including a study in patients with solid tumors and a single-dose study in healthy participants to assess safety and absorption.

Who makes LY2584702?

LY2584702 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The drug is an investigational small molecule that has been studied in early-stage clinical trials for oncology and healthy participant indications.

What phase is LY2584702 in?

LY2584702 is in Phase 1 clinical development. It has completed two Phase 1 trials: one in patients with solid tumors in Japan and another in healthy participants in Singapore. The drug is investigational and not approved for any use.

What clinical trials is LY2584702 in?

LY2584702 has been studied in two completed Phase 1 trials. NCT01241461 evaluated the drug in patients with solid tumors in Japan, enrolling 9 participants. NCT01372085 was a single-dose study in healthy participants in Singapore, enrolling 29 participants. Both trials are completed.

How does LY2584702 work?

LY2584702 is a small molecule being investigated for its potential anti-cancer activity. Its specific molecular target has not been disclosed in the available clinical trial information. The drug was studied in a Phase 1 trial for solid tumors and in a healthy participant study to evaluate its safety and absorption.