A Study of LY2775240 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY2775240; Drug: Placebo; Drug: Apremilast

• Registration Number: NCT02963779
• Lead Sponsor: Eli Lilly and Company

Brief Summary

This study is conducted to determine the side effects related to LY2775240 given orally to healthy participants. Blood tests will be done to check how much LY2775240 is absorbed into the bloodstream and how long the body takes to get rid of it. Each participant will enroll in either Part A or Part B of the study, which will last about 14 weeks and 8 weeks respectively, including screening.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-10
• Study First Submitted QC: 2016-11-10
• Study First Posted: 2016-11-15
• Study Start: 2016-12
• Primary Completion: 2017-10-05
• Study Completion: 2017-10-05
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-03
• Last Update Posted: 2017-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Overtly healthy adult male or a female who cannot get pregnant
• Have a screening body mass index (BMI) of greater than 18 and less than or equal to 32 kilograms per meter square (kg/m²), inclusive
• Have normal blood pressure, pulse rate, electrocardiogram (ECG) and medical test results that are acceptable for the study

Exclusion Criteria

• Are currently participating in or completed a clinical trial within the last 30 days from a clinical trial or any other type of medical research judged to be incompatible with this study
• Have known allergies to compounds or drugs similar to LY2775240 or apremilast
• Have previously participated or withdrawn from this study
• Have or used to have health problems or medical test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LY2775240 (Part A)	LY2775240	Escalating oral doses of LY2775240 administered in healthy participants
Placebo (Part A)	Placebo	Placebo administered orally in healthy participants
LY2775240 (Part B)	LY2775240	Oral dose of LY2775240 in healthy participants
Apremilast (Part B)	Apremilast	Oral dose of apremilast in healthy participants

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline through to final follow-up at approximately Week 14

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: Time to Maximal Blood Concentration of LY2775240	Baseline through Day 5
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2775240	Baseline through Day 5
Pharmacokinetics: Maximum Concentration of LY2775240 in Blood	Baseline through Day 5

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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.; 🇸🇬 Singapore, Singapore