A Multiple-Dose Study of LY3502970 in Healthy Participants

Healthy Clinical Trial

Official title:

A Phase 1 Multiple Dose Study to Investigate the Pharmacokinetics, Safety, and Tolerability of LY3502970 in Fed and Fasted Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05110794
• Other study ID #: 18277
• Secondary ID: J2A-MC-GZGJ
• Status: Completed
• Phase: Phase 1
• Start date: November 5, 2021
• Est. completion date: February 10, 2022

Study information

• Verified date: June 15, 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 10, 2022
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3502970
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 Observed Concentration (Cmax) of LY3502970	PK: Cmax of LY3502970	Predose up to 41 days postdose
Primary	PK: Area Under the Concentration-time curve from 0 to 24 hour (AUC0-24) of LY3502970	PK: AUC0-24 of LY3502970	Predose up to 41 days postdose
Primary	PK: Time to Maximum Observed Concentration (Tmax) of LY3502970	PK: Tmax of LY3502970	Predose up to 41 days postdose