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A Study of LY3202626 in Healthy Participants

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ClinicalTrials.gov Identifier: NCT03023826
Recruitment Status : Completed
First Posted : January 18, 2017
Results First Posted : April 19, 2021
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Healthy Drug: LY3202626 (R-Fasting) Drug: LY3202626 (T1-Fasting) Drug: LY3202626 (T1-Fed) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Relative Bioavailability and Food Effect Study in Healthy Subjects Administered Two Different Formulations of LY3202626
Study Start Date : January 15, 2017
Actual Primary Completion Date : April 4, 2017
Actual Study Completion Date : April 4, 2017

Arm Intervention/treatment
Experimental: LY3202626 (R-Fasting)
Single oral dose of LY3202626 (R) capsule under fasting conditions.
Drug: LY3202626 (R-Fasting)
Administered orally

Experimental: LY3202626 (T1-Fasting)
Single oral dose of LY3202626 (T1) tablet under fasting conditions.
Drug: LY3202626 (T1-Fasting)
Administered orally

Experimental: LY3202626 (T1-Fed)
Single oral dose of LY3202626 (T1) following a high fat breakfast.
Drug: LY3202626 (T1-Fed)
Administered orally




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023826


Locations
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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, Singapore, 117597
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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 Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] September 10, 2016
Statistical Analysis Plan  [PDF] January 17, 2017

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03023826    
Other Study ID Numbers: 15567
I7X-MC-LLCE ( Other Identifier: Eli Lilly and Company )
First Posted: January 18, 2017    Key Record Dates
Results First Posted: April 19, 2021
Last Update Posted: April 19, 2021
Last Verified: March 2021