A Study of LY2969822 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: LY2969822; Drug: Placebo

• Registration Number: NCT02018887
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purpose of this study is to evaluate how safe LY2969822 (study drug) is and whether it causes any side effects. The study will also measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of the study drug. This is the first time that this study drug is being given to participants. This study is for research purposes only and is not intended to treat any medical condition.

Detailed Description

Participants in Part A will complete three study periods, which together will last about 40 days. Participants in Parts B and C will complete one study period which will last about 17 days, but the total study time is about 40 days. Each participant may only enroll in one part. Screening is required within 28 days prior to the start of the study for all participants.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-12
• Study First Submitted QC: 2013-12-17
• Study First Posted: 2013-12-23
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Results First Submitted: 2017-10-21
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-19
• Last Update Submitted: 2019-02-19
• Results First Posted: 2019-02-21
• Last Update Posted: 2019-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• Male participants must agree to use a reliable method of birth control in addition to having their partner use another method for the duration of the study and for 3 months after the last dose of LY2969822
• Female participants must not be of child-bearing potential
• Participants have a body mass index (BMI) of 18.5 to 29.9 kilogram per meter square (kg/m^2), inclusive, at screening

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Exclusion Criteria

• Have participated, within the last 30 days (prior to first dose in this study), in a clinical trial involving an investigational product
• Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
• Intended use of over-the-counter medication within 14 days prior to dosing or during the study with the exception of vitamins and mineral supplements or occasional paracetamol or acetaminophen
• Intended use of herbal supplements or prescription medications, other than stable doses of thyroid or estrogen hormone replacement, within 14 days prior to dosing or during the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LY2969822 (Part A)	LY2969822	Single dose of LY2969822 administered orally in 2 of 3 study periods.
Placebo (Part A)	Placebo	Single dose of placebo administered orally in 1 of 3 study periods.
LY2969822 (Part C)	LY2969822	LY2969822 administered orally for 14 days.
Placebo (Part B)	Placebo	Placebo administered orally for 14 days.
Placebo (Part C)	Placebo	Placebo administered orally for 14 days.
LY2969822 (Part B)	LY2969822	LY2969822 administered orally for 14 days.

Primary Outcome Measures

Name	Time	Method
Number of Participants With One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline Through End of Study (up to Week 7)	A summary of other nonserious adverse events (AEs) and all SAEs, regardless of causality, is located in the Reported Adverse Events section.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Plasma Concentration (Plasma Cmax) of Prodrug LY2969822 and Active Metabolite LSN2934747	All Cohorts: Day 1 - 0 Hours (H), 0.5 H, 1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H; Cohort 3: Day 10 - 0 H, 0.5 H, 1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H; Cohorts 3 - 8: Day 14 - 0 H, 0.5 H,1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H	Pharmacokinetics (PK): Maximum Plasma Concentration (Plasma Cmax) of Prodrug LY2969822 and Active Metabolite LSN2934747
PK: Area Under the Drug Plasma Concentration Time Curve (Plasma AUC) of Prodrug LY2969822 and Active Metabolite LSN2934747	All Cohorts: Day 1 - 0 Hours (H), 0.5 H, 1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H; Cohort 3: Day 10 - 0 H, 0.5 H, 1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H; Cohorts 3 - 8: Day 14 - 0 H, 0.5 H,1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H	For Cohorts 1-2, AUC is extrapolated from time zero to infinity (AUC\[0-inf\]). For Cohorts 3 - 8, AUC is reported during one dosing interval (AUC\[tau\]). AUC(tau) is 24 hours for Cohorts 3 - 5 and 12 hours for Cohorts 6 - 8.
PK: Maximum Cerebrospinal Fluid Concentrations (CSF Cmax) of Prodrug LY2969822 and Active Metabolite LSN2934747	Cohort 8: Day 14 - 0 H, 0.5 H,1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H	PK: Maximum Cerebrospinal Fluid Concentrations (CSF Cmax) of Prodrug LY2969822 and Active Metabolite LSN2934747
PK: CSF AUC(Tau) of Prodrug LY2969822 and Active Metabolite LSN2934747	Cohort 8: Day 14 - 0 H, 0.5 H,1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H	AUC(tau) is 12 hours.

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇸🇬 Singapore, Singapore