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A Study of Two Different Formulations of LY3502970 in Healthy Participants

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Lilly

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: LY3502970

Study type

Interventional

Funder types

Industry

Identifiers

NCT05341089
J2A-MC-GZGH (Other Identifier)
17785

Details and patient eligibility

About

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.

Enrollment

39 patients

Sex

All

Ages

21 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

39 participants in 2 patient groups

LY3502970 (Formulation 1)
Experimental group
Description:
LY3502970 administered orally.
Treatment:
Drug: LY3502970
LY3502970 (Formulation 2)
Experimental group
Description:
LY3502970 administered orally.
Treatment:
Drug: LY3502970

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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