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OpenTrials
Completed

NCT Number: NCT05778864

A Study of LY3473329 in Participants With Impaired and Normal Renal Function

The main purpose of this study is to assess the amount of study drug (LY3473329) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to participants with normal renal function. The safety and tolerability of LY3473329 will also be evaluated in these participants. The study will last up to 8 weeks including screening period.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Velocity Clinical Research, New Smyrna Beach, Edgewater, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²)
  • Men who agree to use highly effective or effective methods of contraception, women of childbearing potential (WOCP) who agree to use highly effective or effective methods of contraception, and women not of childbearing potential (WNOCBP) may participate in this trial
  • Have clinical laboratory test results within the normal reference range for the population

Exclusion criteria

  • Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that, in the opinion of the investigator, would potentially affect participant safety within the study
  • Have any abnormality in the 12-lead electrocardiogram (ECG), blood pressure and/or pulse rate that, in the opinion of the investigator, increases the risks associated with participating in the study
  • Hemoglobin less than 8 grams/deciliter (g/dL) and/or clinically significant anemia symptoms
  • Have an average weekly alcohol intake that exceeds 21 units per week for males and 14 units per week for females or males older than 65 years of age
  • Smoke more than 10 cigarettes per day or the equivalent
  • Have donated blood of more than 500 milliliter (mL) within 3 months prior to screening

Treatment and study plan

LY3473329

Drug

Administered orally.

Primary outcomes

  1. Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3473329

    Time frame: Predose up to 34 days postdose

    PK: AUC0-∞ of LY3473329

  2. PK: Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3473329

    Time frame: Predose up to 34 days postdose

    PK: AUC0-tlast of LY3473329

  3. PK: Maximum observed concentration (Cmax) of LY3473329

    Time frame: Predose up to 34 days postdose

    PK: Cmax of LY3473329

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Pharmacokinetics of LY3473329 Following Oral Administration in Participants With Renal Impairment Compared With Participants With Normal Renal Function

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 21, 2023
Registry last updated
Oct 28, 2024

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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