A Study of LY3871801 in Healthy Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05222399
• Other study ID #: 18323
• Secondary ID: J3P-MC-FTAB
• Status: Completed
• Phase: Phase 1
• Start date: February 4, 2022
• Est. completion date: March 11, 2022

Study information

• Verified date: March 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 11, 2022
• Est. primary completion date: March 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3871801
Administered orally.

Locations

Country	Name	City	State
Singapore	Lilly Centre for Clinical Pharmacology	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3871801	PK: Cmax of LY3871801	Predose through Day 4
Primary	PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of LY3871801	PK: AUC[0-8] of LY3871801	Predose through Day 4