A Study of LY3337641 in Japanese and Caucasian Healthy Participants

NCT ID: NCT03083561

Last Updated: 2023-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-15
• Study Completion Date: 2017-05-25

Brief Summary

The main purpose of this study is to evaluate the safety and tolerability of LY3337641 in healthy Japanese and Caucasian participants. The study will also investigate how the body processes LY3337641 and the effect of LY3337641 on the body. The study will last up to 4 weeks for each participant. Screening may occur within 28 days prior to first dose of study drug.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

LY3337641 Multiple Dose

Multiple doses of 30 mg LY3337641 tablet administered orally every day for two weeks, with a two week follow-up period.

Group Type: EXPERIMENTAL

LY3337641

Intervention Type: DRUG

Administered orally.

Placebo Multiple Dose

Multiple doses of placebo administered orally every day for two weeks, with a two week follow-up period.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered orally.

LY3337641 Single Dose

Single dose of 5 mg, 80 mg and 160 mg LY3337641 tablet administered orally, with a two week follow-up period.

Group Type: EXPERIMENTAL

LY3337641

Intervention Type: DRUG

Administered orally.

Placebo Single Dose

Single dose of placebo administered orally, with a two week follow-up period.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered orally.

Interventions

LY3337641

Administered orally.

Intervention Type: DRUG

Placebo

Administered orally.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Overtly healthy Japanese or Caucasian
• Body mass index (BMI) 18.0 - 32.0 kilograms per square meter (kg/m²)

Exclusion Criteria

• Are currently enrolled in a clinical trial involving an investigational product or off-label use of a drug or device or are concurrently enrolled in 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, if known) should have passed
• Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study or affects or confounds the QTc analysis or have Fridericia-corrected QT interval (QTcF) >450 milliseconds (msec) for males and >470 msec for females
• Have had symptomatic herpes zoster within 3 months of screening
• Have active or latent tuberculosis (TB) based on a positive medical history, examination, and/or TB test results.
• Have received live vaccine(s) within 1 month of screening or intend to during the study
• Are immunocompromised
• Have a history of constipation or have had acute constipation within 3 weeks prior to admission

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

WCCT Global

Cypress, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

I8K-JE-JPDB

Identifier Type: OTHER

Identifier Source: secondary_id

16174

Identifier Type: -

Identifier Source: org_study_id