A Study of LY3871801 in Healthy Participants

NCT05222399 | Completed Phase 1

• 2 other identifiers: 18323J3P-MC-FTAB
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3871801

  PK: Cmax of LY3871801

  Predose through Day 4

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

  PK: AUC\[0-∞\] of LY3871801

  Predose through Day 4

Study Arms (2)

LY3871801 (Period 1)

EXPERIMENTAL

LY3871801 solid dispersion suspension administered orally.

Drug: LY3871801

LY3871801 (Period 2)

EXPERIMENTAL

LY3871801 crystalline freebase tablet administered orally.

Drug: LY3871801

Interventions

LY3871801 DRUG

Administered orally.

LY3871801 (Period 1); LY3871801 (Period 2)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 3, 2022
• Study Start: February 4, 2022
• Primary Completion: March 11, 2022
• Study Completion: March 11, 2022
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)