Clincosm LogoSign in Get a demo

A Study of LY3871801 in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT05222399
Collaborator
(none)
15
Enrollment
1
Location
2
Arms
1.1
Actual Duration (Months)
13
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Pharmacokinetics of LY3871801 Following Oral Administration of a Crystalline Freebase Tablet and a Solid Dispersion Oral Suspension
Actual Study Start Date :
Feb 4, 2022
Actual Primary Completion Date :
Mar 11, 2022
Actual Study Completion Date :
Mar 11, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3871801 (Period 1)

LY3871801 solid dispersion suspension administered orally.

Drug: LY3871801
Administered orally.
Experimental: LY3871801 (Period 2)

LY3871801 crystalline freebase tablet administered orally.

Drug: LY3871801
Administered orally.

Outcome Measures

Primary Outcome Measures

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3871801 [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 [Predose through Day 4]

    PK: AUC[0-∞] of LY3871801

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lilly Centre for Clinical Pharmacology Singapore Singapore 138623

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05222399
Other Study ID Numbers:
  • 18323
  • J3P-MC-FTAB
First Posted:
Feb 3, 2022
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes

Study Results

No Results Posted as of Mar 18, 2022