A Study of LY2775240 in Healthy Participants

A 2-Part, Safety, Tolerability, and Pharmacokinetic Study of LY2775240 in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: LY2775240; Drug: Apremilast

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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• Have previously participated or withdrawn from this study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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY2775240 (Part A); Escalating oral doses of LY2775240 administered in healthy participants	Drug: LY2775240; Administered orally
Experimental: LY2775240 (Part B); Oral dose of LY2775240 in healthy participants	Drug: LY2775240; Administered orally
Placebo Comparator: Placebo (Part A); Placebo administered orally in healthy participants	Drug: Placebo; Administered orally
Active Comparator: Apremilast (Part B); Oral dose of apremilast in healthy participants	Drug: Apremilast; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): October 5, 2017
• Study Completion (Actual): October 5, 2017

Study Registration Dates

• First Submitted: November 10, 2016
• First Submitted That Met QC Criteria: November 10, 2016
• First Posted (Estimate): November 15, 2016

Study Record Updates

• Last Update Posted (Actual): November 7, 2017
• Last Update Submitted That Met QC Criteria: November 3, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; Apremilast
• Other Study ID Numbers: 16450; I8W-MC-PDBA (Other Identifier: Eli Lilly and Company)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No