A Study to Compare Two Formulations of LY3209590 in Healthy Participants

NCT05914688 | Completed Phase 1

• 2 other identifiers: 18310I8H-MC-BDDF
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to compare the two formulations of LY3209590 in healthy participants. Study participants will be administered each formulation at separate study visits. Blood samples will be taken to compare how the body handles study drugs. The information about any adverse effects experienced will be collected and the tolerability of LY3209590 will also be evaluated. Screening is required within 28 days prior to enrolment. For each participant, the total duration of the clinical trial will be about 184 days including screening.

Conditions

Healthy

Keywords

Pharmacokinetics; Formulation; Bioavailability

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to the Last Time Point (AUC[0-tlast]) of LY3209590

  PK: AUC(0-tlast) of LY3209590

  Predose up to 65 days post dose

• PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3209590

  PK: AUC(0-∞) of LY3209590

  Predose up to 65 days post dose

• PK: Maximum Observed Concentration (Cmax) of LY3209590

  PK: Cmax of LY3209590

  Predose up to 65 days post dose

Study Arms (2)

LY3209590 (Formulation 1)

EXPERIMENTAL

Single dose of LY3209590 as formulation 1 administered subcutaneously (SC).

Drug: LY3209590 (Formulation 1)

LY3209590 (Formulation 2)

EXPERIMENTAL

Single dose of LY3209590 as formulation 2 administered SC.

Drug: LY3209590 (Formulation 2)

Interventions

LY3209590 (Formulation 1) DRUG

Administered SC.

LY3209590 (Formulation 1)

LY3209590 (Formulation 2) DRUG

Administered SC.

LY3209590 (Formulation 2)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants who are overtly healthy as determined by medical evaluation
• Have a body weight of 45 kilograms or more and body mass index (BMI) within the range of 18.5 to 35.0 kilograms per meter squared (kg/m²), inclusive
• Contraceptive use by participants should be consistent with local regulations

You may not qualify if:

• Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
• Have known allergies to LY3209590, related compounds, or any components of the formulation
• Have a history of multiple or severe allergic reactions or a history of severe anaphylactic reaction
• Have an abnormality in the 12-lead electrocardiogram (ECG)
• Are lactating or pregnant

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 22, 2023
• Study Start: June 26, 2023
• Primary Completion: January 18, 2024
• Study Completion: January 18, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)