A Study of LY3316531 in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to assess study drug activity by giving LY3316531 or placebo into a vein in the arm and then measuring blood flow to the skin, after capsaicin is applied to skin's surface. The study will last about 16 weeks inclusive of the screening period.

Official Title
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A Phase 1 Randomized, Placebo-Controlled Study to Determine the Effect of LY3316531 on Capsaicin-Induced Dermal Blood Flow in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3316531
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3316531 Dose 1<br>LY3316531 administered IV | Drug: LY3316531<br>* Administered IV<br>|
| Experimental: LY3316531 Dose 2<br>LY3316531 administered IV | Drug: LY3316531<br>* Administered IV<br>|
| Placebo Comparator: Placebo<br>Placebo administered IV | Drug: Placebo<br>* Administered IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Dermal Blood Flow Induced by LY3316531 Compared to Placebo | Change from Baseline in Dermal Blood Flow Induced by LY3316531 Compared to Placebo | Baseline, Up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY3316531 | Pharmacokinetics: Maximum Concentration (Cmax) of LY3316531 | Baseline through 80 days | 
| Pharmacokinetics: Area Under the Concentration versus Time Curve of LY3316531 | Pharmacokinetics: Area Under the Concentration versus Time Curve of LY3316531 | Baseline through 80 days |