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OpenTrials
Completed

NCT Number: NCT03023826

A Study of LY3202626 in Healthy Participants

The purposes of this study are to determine:

* If there are any differences in the way LY3202626 is handled by the body when taken in two different forms * Whether a high fat meal affects the way the body handles LY3202626 * How well tolerated LY3202626 is

There are three (3) study periods for all participants. Participants will be admitted to the clinical research unit (CRU) each period and will be discharged from the CRU following the completion of 2 overnight stays and up to 36 hours after dosing with LY3202626.

The study will last about 50 days, not including screening.

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Key information

Conditions

Healthy

Age range

21 year and older

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, 117597

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Are overtly healthy males or females, as determined by medical history and physical examination
  • Female participants must be of non-childbearing potential confirmed by medical history or menopause
  • Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive, at screening

Exclusion criteria

  • Are investigative site personnel directly affiliated with this study and their immediate families
  • Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
  • Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed
  • Have previously completed or withdrawn from this study or any other study investigating LY3202626, and have previously received the investigational product
  • Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
  • Have a history of head trauma with loss of consciousness within the last 5 years
  • Have known or ongoing psychiatric disorders

Treatment and study plan

LY3202626 (R-Fasting)

Drug

Administered orally

LY3202626 (T1-Fasting)

Drug

Administered orally

LY3202626 (T1-Fed)

Drug

Administered orally

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3202626

    Time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose

    Pharmacokinetics (PK) is the maximum observed drug concentration (Cmax) of LY3202626

  2. PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3202626

    Time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose

    PK is the area under the concentration versus time curve from time zero to infinity (AUC[0-∞]) of LY3202626

  3. PK: AUC From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3202626

    Time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose

    PK is the AUC from time zero to time t, where t is the last time point with a measurable concentration (AUC[0-tlast]) of LY3202626

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Relative Bioavailability and Food Effect Study in Healthy Subjects Administered Two Different Formulations of LY3202626

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 18, 2017
Registry last updated
Apr 19, 2021

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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