A Study of LY3526318 in Healthy Participants | NCT03977974

NCT03977974

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
J2D-MC-CVAA	Other Identifier	Eli Lilly and Company
2019-001902-80	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LY3526318 - Part A	Experimental	Single-ascending dose (SAD) 10 milligram (mg), 30 mg, 50 mg, or 300 mg LY3526318 administered orally. 100 mg LY3526318 administered orally without a meal in period 1 and 30 mg LY3526318 administered orally with a meal in period 2. 200 mg LY3526318 administered orally without a meal in period 1 and 200 mg LY3526318 administered orally with a meal in period 2. 100 mg LY3526318 Fed: Period 1: 100 mg LY3526318 administered orally 30 minutes (min) after breakfast (Fed (-30 min.)). Period 2: 100 mg LY3526318 orally 30 minutes before breakfast (Fed (+30 min.)). Period 3: 100 mg LY3526318 administered orally 60 minutes before breakfast (Fed (+60 min.)). Placebo Fed: Period 1: Placebo administered orally 30 minutes after breakfast (Fed (-30 min.)). Period 2: Placebo administered orally 30 minutes before breakfast (Fed (+30 min.)). Period 3: Placebo administered orally 60 minutes before breakfast (Fed (+60 min.)).	Drug: LY3526318
Placebo - Part A	Placebo Comparator	Participants received placebo administered orally once.	Drug: Placebo
LY3526318 - Part B	Experimental	Multiple-ascending dose (MAD): 30 mg LY3526318 once daily (QD): Participants received 30 mg LY3526318 QD administered orally for 14 days. MAD: 60 mg LY3526318 QD: Participants received 60 mg LY3526318 QD administered orally for 14 days. MAD: 100 mg LY352631 QD: Participants received 100 mg LY3526318 QD administered orally for 14 days.	Drug: LY3526318
Placebo - Part B	Placebo Comparator

Name	Type	Description	Arm Group Labels	Other Names
LY3526318	Drug	Administered orally	LY3526318 - Part A LY3526318 - Part B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	An SAE is any AE from this study that results in 1 of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e. immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect and important medical events that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent 1 of the other outcomes listed in the definition. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, are reported in the Adverse Events module section.	Baseline Up To 32 Days

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3526318	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3526318	SAD: Day 1: predose, 1, 2, 4, 6, 8 and 12 hours postdose; Day 2 and Day 3: 24 and 48 hours postdose; 3-Period Food Effect Arms: Day 1: Predose, 1, 2, 4, 6, 8 and 12 hours, Day 2, Day 3 and Day 4: Predose, 24, 48 and 72 hours postdose

Eligibility Module

Eligibility Criteria

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

Name	Affiliation	Role
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

Facility	Status	City	State	ZIP	Country	Contacts
PRA Health Sciences		Groningen		9728	Netherlands

Arm/Group Information

ID	Title	Description
FG000	SAD: Placebo	Participants received placebo administered orally.
FG001	SAD: 10 mg LY3526318	Participants received 10 mg LY3526318 administered orally.
FG002	SAD: 30 mg LY3526318	Participants received 30 mg LY3526318 administered orally.
FG003	SAD: 50 mg LY3526318	Participants received 50 mg LY3526318 administered orally.
FG004	SAD: 100 mg LY3526318 (Fasted) and 30 mg LY3526318 (Fed)	Period 1: Participants received 100 mg LY3526318 administered orally without a meal. Period 2: Participants received 30 mg LY3526318 administered orally with a meal.
FG005	SAD: 200 mg LY3526318 (Fasted) and 200 mg LY3526318 (Fed)	Period 1: Participants received 200 mg LY3526318 administered orally without a meal. Period 2: Participants received 200 mg LY3526318 administered orally with a meal.
FG006	SAD: 300 mg LY3526318	Participants received 300 mg LY3526318 administered orally.
FG007	SAD: 100 mg LY3526318 Fed	Period 1: Participants received 100 mg LY3526318 administered orally 30 minutes after breakfast (Fed [-30 min.]) Period 2: Participants received 100 mg LY3526318 orally 30 minutes before breakfast (Fed [+30 min.]) Period 3: Participants received 100 mg LY3526318 administered orally 60 minutes before breakfast (Fed [+60 min.])
FG008	SAD: Placebo Fed	Period 1: Participants received placebo administered orally 30 minutes after breakfast (Fed [-30 min.]) Period 2: Participants received placebo administered orally 30 minutes before breakfast (Fed [+30 min.]) Period 3: Participants received placebo administered orally 60 minutes before breakfast (Fed [+60 min.])
FG009	MAD: Placebo QD	Participants received placebo once daily (QD) administered orally for 14 days.
FG010	MAD: 30 mg LY3526318 QD	Participants received 30 mg LY3526318 QD administered orally for 14 days.
FG011	MAD: 60 mg LY3526318 QD	Participants received 60 mg LY3526318 QD administered orally for 14 days.
FG012	MAD: 100 mg LY352631 QD	Participants received 100 mg LY3526318 QD administered orally for 14 days.

Periods

Title

Milestones

Reasons Not Completed

Period 1

Type	Comment	Milestone Data
STARTED		FG00012 subjects FG0016 subjects FG0026 subjects FG0036 subjects FG0046 subjects FG0056 subjects FG0066 subjects FG0073 subjects FG0081 subjects FG0096 subjects FG0106 subjects FG0116 subjects FG0126 subjects
Received at Least One Dose of Study Drug		FG00012 subjects FG0016 subjects FG0026 subjects FG0036 subjects
COMPLETED		FG00012 subjects FG0016 subjects FG0026 subjects FG0036 subjects FG004
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004

Period 2

Type	Comment	Milestone Data
STARTED		FG0000 subjectsPeriod 2 does not apply to this arm. FG0010 subjectsPeriod 2 does not apply to this arm. FG0020 subjectsPeriod 2 does not apply to this arm. FG003

Period 3

Type	Comment	Milestone Data
STARTED		FG0000 subjectsPeriod 3 does not apply to this arm. FG0010 subjectsPeriod 3 does not apply to this arm. FG0020 subjectsPeriod 3 does not apply to this arm. FG003

Baseline Characteristics Module

ID	Title	Description
BG000	SAD: Placebo	Participants received placebo administered orally.
BG001	SAD: 10 mg LY3526318	Participants received 10 mg LY3526318 administered orally..

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

An SAE is any AE from this study that results in 1 of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e. immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect and important medical events that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent 1 of the other outcomes listed in the definition. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, are reported in the Adverse Events module section.

All participants who received at least one dose of study drug.

Posted

Count of Participants

Participants

Baseline Up To 32 Days

ID	Title	Description
OG000	SAD: Placebo

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	SAD: Placebo	Participants received placebo administered orally.	0

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 16, 2019	Feb 22, 2021	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Apr 7, 2020	Feb 22, 2021	SAP_001.pdf