A First-In-Human Study of LY3839840 in Healthy Participants

Healthy Clinical Trial

Official title:

Single- and Multiple-Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of LY3839840 Following Oral Dosing in Healthy Participants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06153355
• Other study ID #: 18798
• Secondary ID: J4U-MC-KTAA
• Status: Recruiting
• Phase: Phase 1
• Start date: December 4, 2023
• Est. completion date: August 2024

Study information

• Verified date: June 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]Lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this first-in-human study to investigate the safety of LY3839840 in single and multiple doses, and how it's processed in the body when given in different amounts.

Description:

The study will be conducted in four parts (A, B, C and D) and each enrolled participant will receive a single dose (Parts A and C) or multiple dose (Parts B, C and D) of either LY3839840 or placebo. The study will last up to approximately 7 weeks for parts A, C (single dose cohort) and 8 weeks for parts B, D and C (multiple dose cohort).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Participants must be overtly healthy, as determined by medical evaluation.

• Males who agree to follow contraceptive requirements, or women not of childbearing potential (WNOCBP).

• Have a body mass index (BMI) of greater than (>)18 to less than or equal to (=35) kilograms per square meter (kg/m²). For Part C and D: BMI within the range of 18 to 29 kg/m².

• Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study.

• Have venous access sufficient to allow for blood sampling.

For Part C:

• Participants must be first-generation Chinese only, defined as the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Chinese descent and born in China.

For Part D:

• Participants must be first-generation Japanese only, defined as the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.

Exclusion Criteria:

• Have known allergies to LY3839840, related compounds, or any components of the formulation.

• Have a history or presence of multiple or severe allergies, anaphylactic reaction to prescription or nonprescription drugs, or history of significant atopy.

• Have a significant history of or current rheumatologic, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (such as Cushing syndrome, hyperthyroidism, hyperaldosteronism), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational medicinal product; or of interfering with the interpretation of data.

• Have had any significant infections within 3 months prior to the screening visit, or develop any of these infections before the randomization visit.

• Have received =1 live vaccine within 28 days of screening, or intend to during the study, or =28 days after the study.

• Had any surgical procedure (except for minor surgery requiring local or no anesthesia and without any complications or sequelae) within 12 weeks prior to screening, or intend to during the study, or =28 days after the study.

• Had any malignancy within the past 5 years. Exceptions: successfully treated basal cell skin carcinoma or squamous cell skin carcinoma with no evidence of recurrence or metastatic disease within the past 3 years.

• Have a history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection that, in the opinion of the sponsor or investigator, poses an unacceptable risk to the participant.

• Have used, or intend to use, prescription or nonprescription medication within 14 days prior to dosing (or 5 half-lives - whichever is longer).

• Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.

• Have participated in a clinical study involving an investigational product within the last 30 days of the final drug administration (or 5 half-lives - whichever is longer).

• Show evidence of active or latent TB.

• Are females who are lactating or have a positive pregnancy test at screening or Day -1.

• Blood donation of =450 mL, or participation in a clinical study that required a blood volume of =400 mL since the last study visit within the past 120 days.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3839840
Administered orally.
• Placebo
Administered orally.

Locations

Country	Name	City	State
United States	CenExel ACT	Anaheim	California
United States	Fortrea Clinical Research Unit	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration	A summary of AEs, TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module	Baseline up to Week 8
Secondary	Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3839840	PK:Cmax of LY3839840	Predose on day 1 up to 14 days post dose
Secondary	PK: Area Under the Concentration Versus Time Curve (AUC) of LY3839840	PK: AUC of LY3839840	Predose on day 1 up to 14 days post dose