A Study of LY3526318 in Healthy Participants

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Terminated

CT.gov ID

NCT03977974

Collaborator

(none)

Enrollment

Location

Arms

8.5

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to learn more about the safety and side effects of LY3526318 when given by mouth to healthy participants. The study will have two parts. Each participant will enroll in only one part. For each participant, Part A will last up to 28 days and Part B will last up to 51 days, including screening and follow-up.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: LY3526318 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

A Safety, Tolerability, Pharmacokinetic, and Pilot Food Effect Study of Single- and Multiple-Ascending Doses of LY3526318 in Healthy Participants

Actual Study Start Date :

Jun 21, 2019

Actual Primary Completion Date :

Mar 5, 2020

Actual Study Completion Date :

Mar 5, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3526318 - Part A LY3526318 administered orally once.	Drug: LY3526318 Administered orally
Placebo Comparator: Placebo - Part A Placebo administered orally once.	Drug: Placebo Administered orally
Experimental: LY3526318 - Part B LY3526318 administered once orally on consecutive days.	Drug: LY3526318 Administered orally
Placebo Comparator: Placebo - Part B Placebo administered once orally on consecutive days.	Drug: Placebo Administered orally

Outcome Measures

Primary Outcome Measures

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Baseline through Study Completion (Part A: Day 38; Part B: Day 51)]
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3526318 [Part A: Predose on Day 1 through Day 3; Part B: Predose on Day 1 through Day 15]
PK: AUC of LY3526318
PK: Maximum Observed Drug Concentration (Cmax) of LY3526318 [Part A: Predose on Day 1 through Day 3; Part B: Predose on Day 1 through Day 15]
PK: Cmax of LY3526318
PK: Time to Cmax (Tmax) of LY3526318 [Part A: Predose on Day 1 through Day 3; Part B: Predose on Day 1 through Day 15]
PK: Tmax of LY3526318

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Part A Cohorts:

Healthy male participants (including self-reported surgically sterile males) must agree to the following:
When engaging in sex with Women of Child-Bearing Potential (WOCBP) both the male participant and his female partner must use highly effective contraception consisting of 2 forms of birth control (1 of which must be a male barrier method such as a latex or polyurethane condom) from start of dosing throughout the clinical study period, and for 90 days after the final study drug administration
Nonsurgically sterile male participants must not donate sperm at any time from start of dosing until 90 days beyond the administration of study drug

All Part A and Part B Cohorts:

Female participants must be nonpregnant and not lactating, or of nonchildbearing potential (either surgically sterilized [e.g. tubal occlusion, hysterectomy, bilateral salpingectomy] or physiologically incapable of becoming pregnant, or postmenopausal with amenorrhea for at least 12 consecutive months). Healthy female participants of child-bearing potential who have a fertile male sexual partner must be willing and able to practice effective contraception from admission to 30 days after the final visit. Sexually active participants must use a combination of 2 of the following methods of contraception, including at least 1 so-called 'barrier' method:
Hormonal contraceptive (oral, transdermal patches, vaginal or injectable)
Intrauterine device with or without hormones
Condom ('barrier' method)
Diaphragm or cervical cap
Sexual abstinence
Have a body mass index 18 to 32 kilograms per square meter (kg/m²)

Exclusion Criteria:

Are currently enrolled in a 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 a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, convulsions, or any clinically significant laboratory abnormality
In the opinion of the investigator are considered to be a danger to themselves
Have an abnormality in the 12-lead electrocardiogram (ECG)
Have a history of clinically significant multiple or severe drug allergies or severe post treatment hypersensitivity reactions
Have donated blood of more than 500 milliliter (mL) within the previous month
Are unwilling to stop alcohol and caffeinated beverage consumption and smoking/use of tobacco while resident in the CRU
Have an average weekly alcohol intake that exceeds 21 units per week (1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits
Have an abnormal blood pressure
Participants with a history of drug abuse
Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer)
Are unwilling to comply with the required dietary restrictions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRA Health Sciences	Groningen		Netherlands	9728

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:

NCT03977974

Other Study ID Numbers:

17426
J2D-MC-CVAA
2019-001902-80

First Posted:

Jun 6, 2019

Last Update Posted:

Apr 22, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Apr 22, 2020