A Study of Two Different Formulations of LY3502970 in Healthy Participants

Healthy Clinical Trial

Official title:

A Phase 1 Multiple-Dose Study to Investigate the Pharmacokinetics, Safety, and Tolerability of 2 Different Formulations of LY3502970 in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05341089
• Other study ID #: 17785
• Secondary ID: J2A-MC-GZGH
• Status: Completed
• Phase: Phase 1
• Start date: May 17, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: September 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 when administered as two different formulations in healthy participants. The study will also evaluate the safety and tolerability of LY3502970. The study will last up to 13 weeks excluding the screening period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 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 who have a hemoglobin level of at least 11.4 grams per deciliter (g/dL) for female participants and at least 12.5 g/dL for male participants

• Participants with a body weight of at least 45 kilograms (kg) and body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m²)

• Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential

Exclusion Criteria:

• Participants who have any abnormality in the 12-lead electrocardiogram (ECG) at screening

• Participants who have an abnormal blood pressure, pulse rate, or both, which are deemed to be clinically significant by the investigator, at screening

• Participants who have known allergies to LY3502970, related compounds, or any components of the formulation

• Participants who have used or intend to use over-the-counter or prescription medication including herbal medications or traditional medications within 14 days prior to dosing

• Participants who show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies, or both. 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, or both. 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, or all. 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	Pre-dose on Day 1 up to 39 days post-dose
Primary	PK: Area Under the Plasma Concentration-Time Curve from 0 to 24 hours (AUC0-24) of LY3502970	PK: AUC0-24 of LY3502970	Pre-dose on Day 1 up to 39 days post-dose
Primary	PK: Time to Maximum Observed Concentration (Tmax) of LY3502970	PK: Tmax of LY3502970	Pre-dose on Day 1 up to 39 days post-dose