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Completed

NCT Number: NCT05222399

A Study of LY3871801 in Healthy Participants

The main purpose of this study is to compare the amount of LY3871801 that gets into the blood stream and how long it takes the body to get rid of it, when given as crystalline freebase tablet (test) and as a solid dispersion oral suspension (reference) in healthy participants. The information about any adverse effects experienced will be collected and the tolerability of LY3871801 will also be evaluated. The study may last up to approximately 15 days excluding the 28 days of screening period.

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Key information

Conditions

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lilly Centre for Clinical Pharmacology

Singapore, 138623

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants who are overtly healthy as determined by medical evaluation including medical history and physical examination.
  • Have body weight ≥ 45 kilograms (kg) and body mass index (BMI) within the range 18.5 to 40.0 kilograms per meter squared (kg/m²)
  • Participants not of childbearing potential

Exclusion criteria

  • Have known allergies to LY3871801, related compounds or any components of the formulation, or history of significant atopy.
  • Have an abnormal blood pressure and/or pulse rate, deemed to be clinically significant by the investigator
  • Have used or intend to use prescription or nonprescription medication (including dietary supplements, vitamins, herbal supplements, and/or alternative medicines) within 7 days prior to dosing
  • History of drug or alcohol abuse in the past 2 years and/or regularly use known drugs of abuse
  • Are unwilling to stop alcohol consumption 24 hours prior to admission and while resident at the clinical research unit (CRU).
  • Smoke more than 10 cigarettes per day (or the equivalent, including electronic cigarettes) or are unable to abide by the CRU smoking restrictions.

Treatment and study plan

LY3871801

Drug

Administered orally.

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3871801

    Time frame: Predose through Day 4

    PK: Cmax of LY3871801

  2. PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3871801

    Time frame: Predose through Day 4

    PK: AUC[0-∞] of LY3871801

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Pharmacokinetics of LY3871801 Following Oral Administration of a Crystalline Freebase Tablet and a Solid Dispersion Oral Suspension

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 3, 2022
Registry last updated
Mar 18, 2022

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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