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Completed

NCT Number: NCT03611608

A Study of LY3316531 in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3316531

Drug

Administered IV

Placebo

Drug

Administered IV

Primary outcomes

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

    Time frame: Baseline, Day 24

    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

Secondary outcomes

  1. Pharmacokinetics: Maximum Concentration (Cmax) of LY3316531

    Time frame: 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: Maximum Concentration (Cmax) of LY3316531 was reported.

  2. Pharmacokinetics: Area Under Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY3316531

    Time frame: 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 was reported

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 2, 2018
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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