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A Study of Two Different Formulations of LY3502970 in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05341089
Collaborator
(none)
38
Enrollment
1
Location
2
Arms
3.8
Anticipated Duration (Months)
10.1
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 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
38 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 2 Different Formulations of LY3502970 in Healthy Participants
Actual Study Start Date :
May 17, 2022
Anticipated Primary Completion Date :
Sep 9, 2022
Anticipated Study Completion Date :
Sep 9, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3502970 (Formulation 1)

LY3502970 administered orally.

Drug: LY3502970
Administered orally.
Experimental: LY3502970 (Formulation 2)

LY3502970 administered orally.

Drug: LY3502970
Administered orally.

Outcome Measures

Primary Outcome Measures

  1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 [Pre-dose on Day 1 up to 39 days post-dose]

    PK: Cmax of LY3502970

  2. PK: Area Under the Plasma Concentration-Time Curve from 0 to 24 hours (AUC0-24) of LY3502970 [Pre-dose on Day 1 up to 39 days post-dose]

    PK: AUC0-24 of LY3502970

  3. PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 [Pre-dose on Day 1 up to 39 days post-dose]

    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 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lilly Centre for Clinical Pharmacology Singapore Singapore 138623

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:
NCT05341089
Other Study ID Numbers:
  • 17785
  • J2A-MC-GZGH
First Posted:
Apr 22, 2022
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
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

Study Results

No Results Posted as of Aug 9, 2022