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OpenTrials
Completed

NCT Number: NCT02963779

A Study of LY2775240 in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Have previously participated or withdrawn from this study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

Treatment and study plan

LY2775240

Drug

Administered orally

Placebo

Drug

Administered orally

Apremilast

Drug

Administered orally

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

    Time frame: Baseline through to final follow-up at approximately Week 14

Secondary outcomes

  1. Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2775240

    Time frame: Baseline through Day 5

  2. Pharmacokinetics: Time to Maximal Blood Concentration of LY2775240

    Time frame: Baseline through Day 5

  3. Pharmacokinetics: Maximum Concentration of LY2775240 in Blood

    Time frame: Baseline through Day 5

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 15, 2016
Registry last updated
Nov 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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