A Study of LY3337641 in Healthy Participants

Relative Bioavailability and the Effect of Food on the Bioavailability of LY3337641 in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Reference Formulation (R); Drug: LY3337641 (T1); Drug: LY3337641 (T2)

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, 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
    • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3337641 (R-fasted); A single, PO dose of reference formulation (R) given orally with water after an overnight fast in one of four periods.	Drug: Reference Formulation (R); Administered PO
Experimental: LY3337641 (T1-fasted); A single, PO dose of LY3337641(20mg) test formulation 1 (T1) given orally with water after an overnight fast in one of four periods.	Drug: LY3337641 (T1); 20 mg PO
Experimental: LY3337641 (T1-fed); A single, PO dose of LY3337641 (20mg) test formulation 1 (T1) given orally with water after a high fat meal in one of four periods.	Drug: LY3337641 (T1); 20 mg PO
Experimental: LY3337641 (T2-fasted); A single, PO dose of LY3337641 (20 mg) test formulation 2 (T2) given orally with water after an overnight fast in one of four periods.	Drug: LY3337641 (T2); 20 mg PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641	Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641	Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3337641	Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3337641	Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: 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 record dates

Study Major Dates

• Study Start (Actual): April 4, 2017
• Primary Completion (Actual): May 31, 2017
• Study Completion (Actual): May 31, 2017

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: March 30, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 16298; I8K-MC-JPDF (Other Identifier: Eli Lilly and Company)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No