A Study of LY2775240 in Healthy Participants

NCT02963779 | Completed Phase 1

• 2 other identifiers: 16450I8W-MC-PDBA
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (4)

LY2775240 (Part A)

EXPERIMENTAL

Escalating oral doses of LY2775240 administered in healthy participants

Drug: LY2775240

LY2775240 (Part B)

EXPERIMENTAL

Oral dose of LY2775240 in healthy participants

Drug: LY2775240

Placebo (Part A)

PLACEBO COMPARATOR

Placebo administered orally in healthy participants

Drug: Placebo

Apremilast (Part B)

ACTIVE COMPARATOR

Oral dose of apremilast in healthy participants

Drug: Apremilast

Interventions

LY2775240 DRUG

Administered orally

LY2775240 (Part A); LY2775240 (Part B)

Placebo DRUG

Administered orally

Placebo (Part A)

Apremilast DRUG

Administered orally

Apremilast (Part B)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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

Location

MeSH Terms

Interventions

apremilast

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2016
• First Posted: November 15, 2016
• Study Start: December 1, 2016
• Primary Completion: October 5, 2017
• Study Completion: October 5, 2017
• Last Updated: November 7, 2017

Record last verified: 2017-11

Locations

SG (1)