Clinical trial NCT03611608: A Study of LY3316531 in Healthy Participants
Official title: A Phase 1 Randomized, Placebo-Controlled Study to Determine the Effect of LY3316531 on Capsaicin-Induced Dermal Blood Flow in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-08-02
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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 of the skin, after capsaicin is applied to skin's surface. The study will last about 16 weeks inclusive of the screening period.


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

Primary outcomes:
measure: Change From Baseline in Capsaicin-Induced Dermal Blood Flow Following LY3316531 Compared to Placebo
timeFrame: Baseline, Day 24
Secondary outcomes:
measure: Pharmacokinetics: Maximum Concentration (Cmax) of LY3316531
timeFrame: 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
measure: Pharmacokinetics: Area Under Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY3316531
timeFrame: 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
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: