A Study of LY2775240 in Healthy Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02963779
• Other study ID #: 16450
• Secondary ID: I8W-MC-PDBA
• Status: Completed
• Phase: Phase 1
• First received: November 10, 2016
• Last updated: November 3, 2017
• Start date: December 2016
• Est. completion date: October 5, 2017

Study information

• Verified date: November 2017
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 5, 2017
• Est. primary completion date: October 5, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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• Have previously participated or withdrawn from this study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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY2775240
Administered orally
• Placebo
Administered orally
• Apremilast
Administered orally

Locations

Country	Name	City	State
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.	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2775240		Baseline through Day 5
Secondary	Pharmacokinetics: Time to Maximal Blood Concentration of LY2775240		Baseline through Day 5
Secondary	Pharmacokinetics: Maximum Concentration of LY2775240 in Blood		Baseline through Day 5