A Study of LY3316531 in Healthy Participants

NCT03611608 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: 16667I9H-MC-FFAB2018-000710-38
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• Pharmacokinetics: Maximum Concentration (Cmax) of LY3316531

  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

  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

Study Arms (3)

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

Interventions

LY3316531 DRUG

Administered IV

300 mg LY3316531 Dose 1; LY3316531 Dose 2

Placebo DRUG

Administered IV

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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

Location

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 2, 2018
• Study Start: August 30, 2018
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: August 20, 2024
• Results First Posted: August 20, 2024

Record last verified: 2024-03

Locations

BE (1)