A Study of LY3337641 in Japanese and Caucasian Healthy Participants

A Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3337641 in Japanese and Caucasian Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: LY3337641

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • WCCT Global

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Single Dose; Single dose of placebo administered orally, with a two week follow-up period.	Drug: Placebo; Administered orally.
Experimental: LY3337641 Multiple Dose; Multiple doses of 30 mg LY3337641 tablet administered orally every day for two weeks, with a two week follow-up period.	Drug: LY3337641; Administered orally.
Placebo Comparator: Placebo Multiple Dose; Multiple doses of placebo administered orally every day for two weeks, with a two week follow-up period.	Drug: Placebo; Administered orally.
Experimental: LY3337641 Single Dose; Single dose of 5 mg, 80 mg and 160 mg LY3337641 tablet administered orally, with a two week follow-up period.	Drug: LY3337641; Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Clinically significant events were defined as serious adverse events (SAE). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.	Up To 31 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY3337641	Cmax of LY3337641 was evaluated.	MD: Day 1 pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose,Day 15 pre-dose,0.25,0.5,1,2,3,4,6,8,10,12,24,36,48,96,168,240 and 336 hours post-dose. SD: pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12,24,36,48,168 and 336 hours post-dose
PK: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) of LY3337641	AUC from zero to 24-hour of LY3337641 was evaluated.	MD: Day 1 pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose,Day 15 pre-dose,0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose. SD: pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose
PK: Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3337641	AUC from zero to infinity of LY3337641 was evaluated. For 30mg LY3337641 MD Day 1, pharmacokinetic data up to 24-hour post-dose were used for pharmacokinetic parameters calculation.	MD: Day 1 pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose,Day 15 pre-dose,0.25,0.5,1,2,3,4,6,8,10,12,24,36,48,96,168,240 and 336 hours post-dose. SD: pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12,24,36,48,168 and 336 hours post-dose

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): March 15, 2017
• Primary Completion (Actual): May 25, 2017
• Study Completion (Actual): May 25, 2017

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (Actual): March 20, 2017

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 16174; I8K-JE-JPDB (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