A Multiple-Dose Study of LY3502970 in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05110794
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
3.1
Anticipated Duration (Months)
9.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to conduct blood tests to measure how much LY3502970 is in the bloodstream and how the body handles and eliminates LY3502970 in healthy participants in fed and fasted states. The study will also evaluate the safety and tolerability of LY3502970 in these participants. The study will last up to 49 days excluding the screening period.

Condition or DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Phase 1 Multiple Dose Study to Investigate the Pharmacokinetics, Safety, and Tolerability of LY3502970 in Fed and Fasted Healthy Participants
Actual Study Start Date :
Nov 5, 2021
Anticipated Primary Completion Date :
Feb 7, 2022
Anticipated Study Completion Date :
Feb 7, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: LY3502970 (Fed)

LY3502970 administered orally to participants who are in a fed state.

Drug: LY3502970
Administered Orally.

Experimental: LY3502970 (Fasted)

LY3502970 administered orally to participants who are in a fasted state.

Drug: LY3502970
Administered Orally.

Outcome Measures

Primary Outcome Measures

  1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 [Predose up to 41 days postdose]

    PK: Cmax of LY3502970

  2. PK: Area Under the Concentration-time curve from 0 to 24 hour (AUC0-24) of LY3502970 [Predose up to 41 days postdose]

    PK: AUC0-24 of LY3502970

  3. PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 [Predose up to 41 days postdose]

    PK: Tmax of LY3502970

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Are overtly healthy as determined by medical evaluation.

  • Participants with body weight of 45 kilograms (kg) or more and body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m²).

Exclusion Criteria:
  • Participants who have an abnormal blood pressure and/or pulse rate, deemed to be clinically significant by the investigator at screening.

  • Participants who used or intend to use over-the-counter (OTC) or prescription medication and/or herbal/vitamin/traditional medicines or mineral supplements that may affect the safety or objectives of the study, within 14 days prior to dosing and for the duration of the study. Paracetamol and Covid-19 vaccinations are permitted.

  • Participants who are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study.

  • Participants who show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies. A negative test within 6 months of screening would not need to be repeated.

  • Participants who show evidence of hepatitis C and/or positive hepatitis C antibody. A negative test within 6 months of screening would not need to be repeated.

  • Participants who show evidence of hepatitis B, positive hepatitis B surface antigen, and/or positive hepatitis B core antibody. A negative test within 6 months of screening would not need to be repeated.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Lilly Centre for Clinical PharmacologySingaporeSingapore138623

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:
NCT05110794
Other Study ID Numbers:
  • 18277
  • J2A-MC-GZGJ
First Posted:
Nov 8, 2021
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 15, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eli Lilly and Company

Study Results

No Results Posted as of Nov 18, 2021