A Study of LY3337641 in Japanese and Caucasian Healthy Participants

NCT03083561 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 16174I8K-JE-JPDB
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY3337641

  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

  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

  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

Study Arms (4)

LY3337641 Multiple Dose

EXPERIMENTAL

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

Drug: LY3337641

Placebo Multiple Dose

PLACEBO COMPARATOR

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

Drug: Placebo

LY3337641 Single Dose

EXPERIMENTAL

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

Drug: LY3337641

Placebo Single Dose

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

LY3337641 DRUG

Administered orally.

LY3337641 Multiple Dose; LY3337641 Single Dose

Placebo DRUG

Administered orally.

Placebo Multiple Dose; Placebo Single Dose

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

WCCT Global

Cypress, California, 90630, United States

Location

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 20, 2017
• Study Start: March 15, 2017
• Primary Completion: May 25, 2017
• Study Completion: May 25, 2017
• Last Updated: August 25, 2023
• Results First Posted: August 25, 2023

Record last verified: 2022-10

Locations

US (1)