A Study of LY3337641 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Reference Formulation (R); Drug: LY3337641 (T1); Drug: LY3337641 (T2)

• Registration Number: NCT03099148
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-03-30
• Study Start: 2017-04-04
• Study First Posted: 2017-04-04
• Primary Completion: 2017-05-31
• Study Completion: 2017-05-31
• Results First Submitted: 2022-11-11
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-16
• Last Update Submitted: 2023-10-16
• Results First Posted: 2023-10-17
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LY3337641 (R-fasted)	Reference Formulation (R)	A single, PO dose of reference formulation (R) given orally with water after an overnight fast in one of four periods.
LY3337641 (T1-fasted)	LY3337641 (T1)	A single, PO dose of LY3337641(20mg) test formulation 1 (T1) given orally with water after an overnight fast in one of four periods.
LY3337641 (T1-fed)	LY3337641 (T1)	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.
LY3337641 (T2-fasted)	LY3337641 (T2)	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.

Primary Outcome Measures

Name	Time	Method
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	Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC\[0-∞\]) 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): Maximum Observed Drug Concentration (Cmax) of LY3337641

Trial Locations

Locations (2)

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

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