A Multiple Dose Study of LY3502970 in Healthy Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05051566
• Other study ID #: 17783
• Secondary ID: J2A-MC-GZGDQSC20
• Status: Completed
• Phase: Phase 1
• Start date: September 16, 2021
• Est. completion date: April 4, 2022

Study information

• Verified date: April 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 assess how fast LY3502970 gets into the blood stream and how long it takes the body to remove it when administered in multiple oral doses as new formulation compared to that of reference LY3502970 formulation. Information about safety and tolerability will be collected. The study is open to healthy participants. The study is conducted in two parts and it will last up to about 6 months, inclusive of screening period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 4, 2022
• Est. primary completion date: April 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Are overtly healthy as determined by medical evaluation.
• Body mass index (BMI) of 18.5 to 35 kilograms per meter squared (kg/m²).

Exclusion Criteria:

• Have an abnormal blood pressure and/or pulse rate as determined by the investigator -minor deviations acceptable to investigator are allowed
• Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) greater than 2X ULN (Upper Limit of Normal)
• Have an abnormality in the 12-lead ECG at screening that, in the opinion of the investigator, increases the risks associated with participating in the study
• Are women of child-bearing potential
• Are women who are lactating

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3502970
Administered orally.
• Esomeprazole
Administered orally.

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical Ltd	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Quotient Sciences

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970	PK: Cmax of LY3502970	Predose up to 24 hours postdose
Primary	PK: Area Under the Concentration Versus Time Curve (AUC) of LY3502970	PK: AUC of LY3502970	Predose up to 24 hours postdose
Primary	PK: Time of Maximum Observed Concentration (Tmax) of LY3502970	PK: Tmax of LY3502970	Predose up to 24 hours postdose