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Completed

NCT Number: NCT03083561

A Study of LY3337641 in Japanese and Caucasian Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

WCCT Global

Cypress, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3337641

Drug

Administered orally.

Placebo

Drug

Administered orally.

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

    Time frame: Up To 31 Days

    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.

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY3337641

    Time frame: 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

    Cmax of LY3337641 was evaluated.

  2. PK: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) of LY3337641

    Time frame: 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

    AUC from zero to 24-hour of LY3337641 was evaluated.

  3. PK: Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3337641

    Time frame: 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

    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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 20, 2017
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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