A Study of LY3316531 in Healthy Participants | NCT03611608

NCT03611608

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
I9H-MC-FFAB	Other Identifier	Eli Lilly and Company
2018-000710-38	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
300 mg LY3316531 Dose 1	Experimental	LY3316531 administered IV	Drug: LY3316531
LY3316531 Dose 2	Experimental	The optional additional cohort (Dose 2) was not implemented as the data desired for treatment effect on dermal blood flow (DBF) was generated at the initial Dose 1 (300mg LY3316531) LY3316531 administered IV	Drug: LY3316531
Placebo	Placebo Comparator	Placebo administered IV	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
LY3316531	Drug	Administered IV	300 mg LY3316531 Dose 1 LY3316531 Dose 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Capsaicin-Induced Dermal Blood Flow Following LY3316531 Compared to Placebo	To assess target neutralization of calcitonin gene-related peptide by LY3316531 versus placebo, the capsaicin-induced dermal blood flow was measured at baseline (before administration of LY3316531 or placebo) as well as 24 days after a single intravenous dose of LY3316531 or placebo	Baseline, Day 24

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics: Maximum Concentration (Cmax) of LY3316531	Pharmacokinetics: Maximum Concentration (Cmax) of LY3316531 was reported.	Pre-dose, end of infusion (30min), and 2 hours (h), 6h, 24h, 10 days, 24 days, 38 days, 52 days, 66 days and 80 days post-dose
Pharmacokinetics: Area Under Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY3316531

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be healthy males
Must be abstinent or use condoms with spermicide as well as 1 additional highly effective method of contraception or effective method of contraception during the study and for 5 months following dosing of study drug
Must have a body mass index between 18 to 32.0 kilogram per meter square (kg/m²), inclusive, and a minimum body weight of 50 kilogram (kg)
Must have suitable skin characteristics for the dermal capsaicin challenge and have demonstrated at least a 100 percent (%) increase in dermal flow following capsaicin challenge as part of the screening procedures and measured through laser Doppler imaging (LDI)

Exclusion Criteria:

Must not have evidence of clinically significant active infection, fever of 100.5 degrees Fahrenheit (°F) (38 degrees Centigrade (°C)) or above, at baseline
Must not show evidence of active or latent tuberculosis (TB)
Must not have received live, attenuated live, or non-live vaccine(s) within 28 days of screening or intend to receive during the study
Must not be immunocompromised
Must not have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
Must not have significant allergies to humanised monoclonal antibodies
Have a history of multiple or severe allergies or has had an anaphylactic reaction to prescription or nonprescription drugs or food
Must not have had any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin
Must not have eczema, scleroderma, psoriasis, dermatitis, keloids, tumors, ulcers, burns, flaps, or grafts on their forearm or other abnormality of the skin that may interfere with the study assessments
Must avoid excess tanning throughout the study and cannot cover forearms for 24 hours prior to each treatment period
Must not have excessive hair growth on the volar surface of the forearm or currently using lotions, oils, depilatory preparations, or other topical treatments on a regular basis that cannot be discontinued for the duration of the study; participant must not have used any topical treatments within 7 days of the start of the study

Contacts/Locations Module

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.		Leuven			Belgium

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received placebo as a single saline intravenous (IV) infusion. Capsaicin-induced Dermal Blood Flow (DBF): Topical doses of 20 microliter (µL) capsaicin (1000 microgram (µg)/20 µL) applied to 2 different locations on the participant's forearm to induce an increase in dermal blood flow. A 20 µL topical dose of vehicle was applied to a third location on the forearm.
FG001	300 Milligram (mg) LY3316531	Participants received a single 300 milligram (mg) LY3316531 IV infusion. Capsaicin-induced DBF: Topical doses of 20 microliter (µL) capsaicin [1000 microgram (µg)/20 microliter (µL)] applied to 2 different locations on the participant's forearm to induce an increase in dermal blood flow. A 20 µL topical dose of vehicle was applied to a third location on the forearm.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants received placebo as a single saline IV infusion. Capsaicin-induced DBF: Topical doses of 20 microliter (µL) capsaicin [1000 microgram (µg)/20 microliter (µL)] applied to 2 different locations on the participant's forearm to induce an increase in dermal blood flow. A 20 µL topical dose of vehicle was applied to a third location on the forearm.

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

Change From Baseline in Capsaicin-Induced Dermal Blood Flow Following LY3316531 Compared to Placebo

To assess target neutralization of calcitonin gene-related peptide by LY3316531 versus placebo, the capsaicin-induced dermal blood flow was measured at baseline (before administration of LY3316531 or placebo) as well as 24 days after a single intravenous dose of LY3316531 or placebo

All participants who received at least one injection of LY3316531 or Placebo.

Posted

Mean

Standard Deviation

milliliter/100gram/minute (mL/100g/min)

Baseline, Day 24

ID	Title	Description
OG000	Placebo	Participants received placebo as a single saline IV infusion. Capsaicin-induced DBF: Topical doses of 20 microliter (µL) capsaicin (1000 microgram (µg)/20 µL) applied to 2 different locations on the participant's forearm to induce an increase in dermal blood flow. A 20 µL topical dose of vehicle was applied to a third location on the forearm.

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	Placebo	Participants received placebo as a single saline IV infusion. Capsaicin-induced DBF: Topical doses of 20 microliter (µL) capsaicin (1000 microgram (µg)/20 µL) applied to 2 different locations on the participant's forearm to induce an increase in dermal blood flow. A 20 µL topical dose of vehicle was applied to a third location on the forearm.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 6, 2019	Dec 11, 2019	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Oct 17, 2018	Dec 11, 2019	SAP_001.pdf