A Study of LY3041658 in Healthy Participants

Healthy Clinical Trial

Official title:

A Single Dose, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Injections of LY3041658 in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04653168
• Other study ID #: 17745
• Secondary ID: I7P-MC-DSAE
• Status: Completed
• Phase: Phase 1
• Start date: December 7, 2020
• Est. completion date: May 28, 2021

Study information

• Verified date: June 15, 2021
• 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 evaluate the safety and tolerability of LY3041658 in healthy participants. The study will measure how the body absorbs, breaks down and gets rid of LY3041658.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 28, 2021
• Est. primary completion date: May 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and ECG.

• Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

• Have Body mass index (BMI) within the range 18.5 - 35.0 kilograms per square meter (kg/m2) (inclusive).

Exclusion Criteria:

• Have a significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, immune, neurological, dermatological, or psychiatric disorder capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the Study intervention or interfering with the interpretation of data.

• Have self-perceived dullness or loss of sensation on either side of their abdomen.

• Have any condition that could affect pain perception from an injection.

• Have excessive tattoos or scars over the abdomen, or other factors (eg, rash, excessive folds of skin) that, in the investigator's opinion, would interfere with injection site assessments.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3041658
Administered SC

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	Number of Participants With incidence and severity of Injection Site Reaction (ISR)	Number of Participants With incidence and severity of ISR	Baseline up to Day 15
Primary	Visual Analog Scale (VAS) Score for Injection Site Pain	VAS Score for Injection Site Pain	Baseline up to Day 1
Secondary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3041658	PK: Cmax of LY3041658	Predose up to day 85 postdose
Secondary	PK: Area Under the Concentration Versus Time Curve (AUC) from time 0 to infinity of LY3041658	PK: AUC(0-inf) of LY3041658	Predose up to day 85 postdose