A Study of LY3871801 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3871801

• Registration Number: NCT05222399
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-24
• Study First Submitted QC: 2022-01-24
• Study First Posted: 2022-02-03
• Study Start: 2022-02-04
• Status Verified: 2022-03
• Primary Completion: 2022-03-11
• Study Completion: 2022-03-11
• Last Update Submitted: 2022-03-17
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
LY3871801 (Period 1)	LY3871801	LY3871801 solid dispersion suspension administered orally.
LY3871801 (Period 2)	LY3871801	LY3871801 crystalline freebase tablet administered orally.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3871801	Predose through Day 4	PK: Cmax of LY3871801
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3871801	Predose through Day 4	PK: AUC\[0-∞\] of LY3871801

Trial Locations

Locations (1)

Lilly Centre for Clinical Pharmacology; 🇸🇬 Singapore, Singapore