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A Study of LY3337641 in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099148
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : October 3, 2017
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 amount of LY3337641 in the blood/body when it is taken in different formulations. A total of 3 different formulations of LY3337641 are being tested.
  • How a high-fat meal affects the amount of LY3337641 in the blood/body.
  • How safe and well tolerated LY3337641 is.

The study has four periods. Individuals will participate in all four periods. Each period will include 4 overnight stays (5 days) in the Clinical Research Unit (CRU).

This study is expected to last up to 8 weeks. This includes the initial screening period, the study or dosing period, and the follow up period.


Condition or disease Intervention/treatment Phase
Healthy Drug: LY3337641 (R) Drug: LY3337641 (T1) Drug: LY3337641 (T2) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Relative Bioavailability and the Effect of Food on the Bioavailability of LY3337641 in Healthy Subjects
Actual Study Start Date : April 4, 2017
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : May 31, 2017

Arm Intervention/treatment
Experimental: LY3337641 (R-fasted)
A single dose of LY3337641 reference formulation (R) given orally with water after an overnight fast in one of four periods.
Drug: LY3337641 (R)
Administered orally

Experimental: LY3337641 (T1-fasted)
A single dose of LY3337641 test formulation 1 (T1) given orally with water after an overnight fast in one of four periods.
Drug: LY3337641 (T1)
Administered orally

Experimental: LY3337641 (T1-fed)
A single dose of LY3337641 test formulation 1 (T1) given orally with water after a high fat meal in one of four periods.
Drug: LY3337641 (T1)
Administered orally

Experimental: LY3337641 (T2-fasted)
A single dose of LY3337641 test formulation 2 (T2) given orally with water after an overnight fast in one of four periods.
Drug: LY3337641 (T2)
Administered orally




Primary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641 [ Time Frame: Predose up to 72 hours after each administration of study drug ]
    PK: Cmax of LY3337641

  2. Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3337641 [ Time Frame: Predose up to 72 hours after each administration of study drug ]
    PK: AUC(0-∞) of LY3337641



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 65 Years   (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
  • Have a body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m²) inclusive
  • Have clinical laboratory test results within normal reference range for the population or investigative site
  • Are able and willing to give signed informed consent

Exclusion Criteria:

  • 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 significant history of or current cardiovascular, dermatological (such as eczema, psoriasis, and acne), respiratory, hepatic, renal, gastrointestinal (cholecystectomy is not acceptable), 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 used or intend to use over-the-counter or prescription medication, including herbal medications, within 14 days prior to planned dosing
  • In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study

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): NCT03099148


Locations
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Singapore
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Singapore, Singapore, 117597
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
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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03099148    
Other Study ID Numbers: 16298
I8K-MC-JPDF ( Other Identifier: Eli Lilly and Company )
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No