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OpenTrials
Completed

NCT Number: NCT04352114

A Study of LY3461767 in Healthy Participants

The main purpose of this study in healthy participants is to learn more about the safety of LY3461767 and any side effects that might be associated with it. The study will also measure how much LY3461767 gets into the bloodstream and how long it takes the body to get rid of it. For each participant, the study will last about 11 weeks, including screening.

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Key information

Conditions

Healthy

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lilly Nus Centre for Clin Pharmacology, Singapore

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Are healthy males, or females of non-child-bearing potential
  • Have a body mass index of 18 to 35 kilograms per square meter (kg/m²)
  • Have clinical laboratory tests within normal ranges as judged by investigator
  • Have pulse rate and blood pressure within normal ranges as judged by investigator

Exclusion criteria

  • Have Troponin I results above the upper reference limit, and judged to be clinically significant by the investigator, at screening
  • Have an abnormality in the 12-lead electrocardiogram (ECG) at screening
  • Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders
  • Regularly use known drugs of abuse
  • Have donated blood of more than 450 milliliters (mL), or have participated in a clinical study that required similar blood volume collected within the past 3 months
  • Have an average weekly alcohol intake that exceeds 7 units per week or are unwilling to stop alcohol consumption as required during the study
  • Smoke more than 10 cigarettes per day
  • Are current or former smokers with 30-pack-year smoking history
  • Have a diagnosis or history of any malignancy
  • Have not had appropriate cancer screening, in accordance with country specific guidance

Treatment and study plan

LY3461767 - SC

Drug

Administered SC.

LY3461767 - IV

Drug

Administered IV.

Placebo - SC

Drug

Administered SC.

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: Baseline through Day 29

    A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3461767

    Time frame: Baseline through Day 29

    PK: Cmax of LY3461767

  2. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3461767

    Time frame: Baseline through Day 29

    PK: AUC of LY3461767

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3461767 in Healthy Participants

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 20, 2020
Registry last updated
Feb 5, 2021

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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